Access to Cannabis for Medical Purposes Regulations

Whereas a provision of the annexed Regulations provides for the communication of information obtained under the Regulations to certain classes of persons referred to in paragraph 55(1)(s) of the Controlled Drugs and Substances ActFootnote a and, in the opinion of the Governor in Council, it is necessary to communicate that information to those classes of persons for the proper administration or enforcement of the Act and the Regulations;

cannabis means the substance set out in item 1 of Schedule II to the Act. (cannabis ou chanvre indien)

cannabis oil

cannabis oil means an oil, in liquid form at room temperature of 22 ± 2°C, that contains cannabis in its natural form. (huile de chanvre indien)

designated person

designated person means the individual who is authorized by a registration referred to in section 178 to produce cannabis for the medical purposes of the registered person. (personne désignée)

dried marihuana

dried marihuana means harvested marihuana that has been subjected to any drying process, but does not include seeds. (marihuana séchée)

former Marihuana for Medical Purposes Regulations

former Marihuana for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2013-645 of June 6, 2013 and registered as SOR/2013-119. (ancien Règlement sur la marihuana à des fins médicales)

former Marihuana Medical Access Regulations

former Marihuana Medical Access Regulations means the regulations made by Order in Council P.C. 2001-1146 of June 14, 2001 and registered as SOR/2001-227. (ancien Règlement sur l’accès à la marihuana à des fins médicales)

fresh marihuana

fresh marihuana means freshly harvested marihuana buds and leaves, but does not include plant material that can be used to propagate marihuana. (marihuana fraîche)

(2) Cannabis is considered to be destroyed when it is altered or denatured to such an extent that its consumption and propagation is rendered impossible or improbable.

Marginal note:Drying

(3) The production of marihuana includes subjecting it to a drying process.

Marginal note:Equivalency in dried marihuana

2(1) The provisions of this section apply for determining, for the purposes of these Regulations, the quantity of cannabis other than dried marihuana that is equivalent to a given quantity of dried marihuana.

Marginal note:Substances obtained from a licensed producer and products

(2) The quantity of any fresh marihuana or cannabis oil that is obtained from a licensed producer — and the quantity of any products referred to in paragraphs 4(1)(b) and (c) originating from those substances — that is equivalent to a given quantity of dried marihuana must be calculated by

(a) taking into account the dried marihuana equivalency factor determined under section 79 that the licensed producer has indicated on the label of the fresh marihuana or cannabis oil; and

(b) in the case of products referred to in paragraphs 4(1)(b) and (c), taking into account the weight of the fresh or dried marihuana — or the volume of the cannabis oil — that was used to make them.

Marginal note:Marihuana produced under Part 2 and products

(3) The quantity of any marihuana that is produced under Part 2 — and the quantity of any products referred to in paragraphs 4(1)(b) and (c) originating from that marihuana — that is equivalent to a given quantity of dried marihuana must be calculated by:

(a) considering 5 g of fresh marihuana as equivalent to 1 g of dried marihuana; and

(b) in the case of products referred to in paragraphs 4(1)(b) and (c), taking into account the weight of the fresh or dried marihuana that was used to make them.

Possession

Marginal note:Obtaining substance

3(1) Subject to the other provisions of these Regulations, a person listed in subsection (2) may possess fresh or dried marihuana or cannabis oil and a person listed in subsection (3) may possess cannabis if the person has obtained it

(a) a person who has obtained cannabis for their own medical purposes by producing it as a registered person;

(b) a person who has obtained cannabis — for their own medical purposes or for those of another individual for whom they are responsible — from a designated person;

(c) a person who requires cannabis for their business as a licensed producer and who possesses it in accordance with section 22;

(d) a person who requires cannabis for their business as a licensed dealer;

(e) a person who is employed as an inspector, an analyst, a peace officer, a member of the Royal Canadian Mounted Police or a member of the technical or scientific staff of a department of the Government of Canada or of the government of a province and who possesses the cannabis for the purposes of and in connection with their employment; or

(f) a person who is acting as the agent or mandatary of a person whom they have reasonable grounds to believe is a person referred to in paragraph (e) and who possesses the cannabis for the purpose of assisting that person in the administration or enforcement of any Act or its regulations.

Marginal note:Employee or agent or mandatary

(4) A person may possess fresh or dried marihuana or cannabis oil if the person is an employee of or is acting as the agent or mandatary for a person referred to in paragraph (2)(b) or (c), while acting in the course of their employment or their role as agent or mandatary.

Marginal note:Employee or agent or mandatary

(5) A person may possess cannabis if the person is an employee of or is acting as the agent or mandatary for a person referred to in paragraph (3)(c) or (d), while acting in the course of their employment or their role as agent or mandatary.

Marginal note:Altering substance

4(1) An individual who, in accordance with these Regulations or subsection 65(2.1) of the Narcotic Control Regulations, obtains fresh or dried marihuana or cannabis oil for their own medical purposes or for those of another individual for whom they are responsible, and an individual who, in accordance with these Regulations, produces marihuana for their own medical purposes or those of another person for whom they are the designated person, may alter the chemical or physical properties of

(b) a product resulting from an alteration of a substance referred to in paragraph (a); or

(c) a product that is derived from a product referred to in paragraph (b).

Marginal note:No organic solvents

(2) The individual must not use organic solvents when doing those alterations. For the purposes of this subsection, organic solvent means any organic compound that is highly flammable, explosive or toxic, including petroleum naphtha and compressed liquid hydrocarbons such as butane, isobutane, propane and propylene.

Marginal note:Providing substance

(3) An individual who is responsible for another individual may provide a product referred to in subsection (1) only to that individual.

Marginal note:Possession

(4) An individual may possess a product referred to in subsection (1) if they produced it in accordance with this section or obtained it in accordance with these Regulations.

5(1) A licensed producer may possess cannabis that they have obtained in accordance with the Narcotic Control Regulations if they require it for their business.

Marginal note:Employee or agent or mandatary

(2) A person may possess cannabis referred to in subsection (1) if the person is an employee of or is acting as the agent or mandatary of the licensed producer, while acting in the course of their employment or their role as agent or mandatary.

Marginal note:Possession limit

6(1) An individual who possesses products referred to in paragraphs 4(1)(b) and (c), fresh or dried marihuana or cannabis oil — for their own medical purposes or for those of another individual for whom they are responsible — must not possess a total quantity of those products and substances that exceeds the equivalent of the least of the following amounts:

(a) in the case of substances obtained from a licensed producer or products originating from those substances, 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d),

(b) in the case of marihuana produced in accordance with Part 2 or products originating from it, 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d),

(c) in the case of substances obtained from a hospital by or for an out-patient or products originating from those substances, 30 times the daily quantity of dried marihuana referred to in subparagraph 65.2(c)(iii) of the Narcotic Control Regulations, and

(2) For the purposes of paragraph (1)(c), the quantity of any products referred to in paragraphs 4(1)(b) and (c), fresh marihuana and cannabis oil must be calculated taking into account the dried marihuana equivalency factor determined under section 79 that the licensed producer has indicated on the label of the fresh marihuana or cannabis oil and, in the case of products described in those paragraphs, also taking into account the weight of the fresh or dried marihuana – or the volume of the cannabis oil – that was used to make them.

Health Care Practitioners

Marginal note:Authorized activities

7(1) In addition to being authorized to possess fresh or dried marihuana or cannabis oil in accordance with section 3, a health care practitioner may conduct the following activities in regard to a person who is under their professional treatment:

(2) The health care practitioner may also transfer the substance to an individual who is responsible for the person under their professional treatment.

Marginal note:Medical document

8(1) A medical document provided by a health care practitioner to a person who is under their professional treatment must indicate

(a) the practitioner’s given name, surname, profession, business address and telephone number, the province in which they are authorized to practise their profession and the number assigned by the province to that authorization and, if applicable, their facsimile number and email address;

(a) must be specified as a number of days, weeks or months, which must not exceed one year; and

(b) begins on the day on which the medical document is signed by the practitioner.

Marginal note:Validity of medical document

(3) A medical document is valid for the period of use specified in it.

Marginal note:Attestation

(4) The medical document must be signed and dated by the practitioner providing it and must attest that the information in the document is correct and complete.

Marginal note:Thirty-day limit

9(1) A health care practitioner must not transfer to a person under their professional treatment or an individual who is responsible for that person (both of whom are referred to in this section as the transferee) in a 30-day period a total quantity of fresh marihuana, dried marihuana and cannabis oil that, taking into account the dried marihuana equivalency factor determined under section 79, exceeds the equivalent of 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d) that the practitioner has indicated in the medical document on the basis of which the transfer is made.

(a) the 30-day period beginning on the day on which the practitioner first transfers a substance to the transferee; and

(b) every 30-day period after the period referred to in paragraph (a).

Marginal note:First 30-day period

(3) For the purpose of applying subsection (2), the first 30-day period begins on the day on which the practitioner first transfers a substance to the transferee after the day on which that subsection comes into force, even if the practitioner previously transferred a substance to them.

Marginal note:Additional limit

(4) A health care practitioner must not, at any one time, transfer to the transferee a quantity of the substance that, taking into account the dried marihuana equivalency factor determined under section 79, exceeds the equivalent of 150 g of dried marihuana.

Marginal note:Exclusion

(5) A quantity of the substance that the health care practitioner transfers to the transferee to replace a quantity of the substance that the transferee has returned under section 148 is to be excluded for the purpose of calculating the total quantity referred to in subsection (1).

General Provisions

10 For greater certainty, except in the case of inconsistency with these Regulations, the Narcotic Control Regulations also apply to cannabis referred to in these Regulations.

Marginal note:Further information

11 The Minister may, on receiving an application made under these Regulations, require the submission of any further information that pertains to the information contained in the application and that is necessary for the Minister to process the application.

Marginal note:Police enforcement

12 If, under the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act, the member or person is, in respect of that conduct, exempt from the application of these Regulations.

Marginal note:Alteration of documents

13 It is prohibited to mark, alter or deface a medical document or other document issued under these Regulations.

Marginal note:Providing assistance in administration of substance

14(1) While in the presence of a person who has obtained fresh or dried marihuana or cannabis oil — or who has produced or obtained a product referred to in paragraph 4(1)(b) or (c) — for their own medical purposes, another person may, for the purpose of providing assistance in the administration of the substance to that person, possess that substance.

Marginal note:Possession limit

(2) The person providing assistance must not possess a total quantity of substances that exceeds the equivalent of

(a) in the case of fresh or dried marihuana or cannabis oil, the daily quantity of dried marihuana that the other person is authorized to possess, namely the quantity referred to in paragraph 8(1)(d) of these Regulations or subparagraph 65.2(c)(iii) of the Narcotic Control Regulations; or

(b) in the case of a product referred to in paragraph 4(1)(b) or (c), 5 g of dried marihuana.

Marginal note:Demonstrate authority to possess or produce

15 An individual who, in accordance with these Regulations, possesses or produces fresh or dried marihuana, cannabis oil or marihuana plants or seeds or a product referred to in paragraph 4(1)(b) or (c) must, on demand, demonstrate to a police officer that the possession or production is authorized.

Marginal note:Prohibition — obtaining from more than one source

16(1) It is prohibited to seek or obtain fresh or dried marihuana, cannabis oil or marihuana plants or seeds from more than one source at a time on the basis of the same medical document.

Marginal note:Exception

(2) However, a registration certificate issued by the Minister under Part 2 on the basis of a medical document may be used to

(a) obtain an interim supply of fresh or dried marihuana or cannabis oil from a single licensed producer; and

(b) obtain marihuana plants or seeds from one or more licensed producers.

international obligation means an obligation in respect of cannabis set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)

responsible person in charge means, for the purposes of Division 1 of this Part, the person designated under paragraph 32(1)(b). (personne responsable)

Security Directive

Security Directive means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department of Health, as amended from time to time. (Directive en matière de sécurité)

General Provisions

(2) For the purposes of paragraph (1)(a), additive means anything other than marihuana but does not include any residue of a pest control product or its components or derivatives unless the amount of the residue exceeds any maximum residue limit specified for the product, component or derivative under section 9 or 10 of the Pest Control Products Act.

(2) For the purposes of paragraph (1)(a), additive does not include any residue of a pest control product or its components or derivatives unless the amount of the residue exceeds any maximum residue limit specified for the product, component or derivative under section 9 or 10 of the Pest Control Products Act.

Marginal note:Notice of refusal or revocation

20 If the Minister proposes to refuse to issue, amend or renew a licence or permit or proposes to revoke a licence or permit, other than in the case of a revocation under section 45 or subsection 47(4), 101(1) or 108(1), the Minister must

(a) send the applicant or the holder of the licence or permit a notice that sets out the reasons for the refusal or revocation; and

(b) give the applicant or holder an opportunity to be heard in respect of the refusal or revocation.

Marginal note:Inspection of site

21 In order to confirm any information submitted in support of an application for a licence or an amendment or renewal of a licence, an inspector may, at a time during normal business hours and with the reasonable assistance of the applicant, inspect the site in respect of which the application was made.

DIVISION 1Licensed Producers

SUBDIVISION AAuthorized Activities and General Obligations

Marginal note:Activities

22(1) Subject to subsections (2) to (8) and to the other provisions of these Regulations, a licensed producer may

(b) possess and produce cannabis in its natural form, other than marihuana or cannabis oil, for the purpose of producing cannabis oil, and sell, provide, ship, deliver, transport and destroy that cannabis if it was obtained or produced for that purpose; and

(c) possess and produce cannabis, other than marihuana or cannabis oil, for the purpose of conducting in vitro testing that is necessary to determine the cannabinoid content of marihuana or cannabis oil, and sell, provide, ship, deliver, transport and destroy that cannabis if it was obtained or produced for that purpose.

Marginal note:Cannabis

(2) A licensed producer may sell or provide a substance referred to in subsection (3) to

(b) cannabis in its natural form, other than marihuana or cannabis oil, that was obtained or produced for the purpose of producing cannabis oil; and

(c) cannabis, other than marihuana or cannabis oil, that was obtained or produced for the purpose of conducting in vitro testing that is necessary to determine the cannabinoid content of marihuana or cannabis oil.

(i) a client of that producer or an individual who is responsible for the client,

(ii) a hospital employee, if the possession of the substance is for the purposes of and in connection with their employment, or

(iii) a person to whom an exemption relating to the substance has been granted under section 56 of the Act; and

(b) ship fresh or dried marihuana or cannabis oil to a health care practitioner in the case referred to in subparagraph 130(1)(f)(iii).

Marginal note:Registered person

(5) A licensed producer may sell or provide marihuana plants or seeds to a client who is registered with them on the basis of a registration with the Minister made under Part 2 or to an individual who is responsible for the client.

Marginal note:Activities limited

(6) A licensed producer may conduct an activity referred to in subsection (1), (2), (4) or (5) if the producer

(a) possess marihuana or a substance referred to in paragraph (3)(c) for the purpose of export; and

(b) export it if they do so in accordance with an export permit issued under section 103.

Marginal note:Dwelling place

23 A licensed producer must not conduct any activity referred to in section 22 at a dwelling place.

Marginal note:Activities — indoors and at site

24 A licensed producer must produce, package or label cannabis only indoors and at the producer’s site.

Marginal note:Indoor storage only

25(1) A licensed producer must store cannabis only indoors and at the producer’s site.

Marginal note:Security Directive

(2) A licensed producer must store cannabis, other than marihuana plants, in accordance with the Security Directive.

Marginal note:Identification of licensed producer

26 A licensed producer must include their name, as set out in their licence, on all the means by which the producer identifies themself in relation to cannabis, including advertising, product labels, orders, shipping documents and invoices.

Marginal note:Responsible person in charge present

27 A licensed producer must not perform a transaction involving cannabis unless the responsible person in charge or, if applicable, the alternate responsible person in charge is physically present at the producer’s site.

Marginal note:Safekeeping during transportation

28 A licensed producer must take any steps that are necessary to ensure the safekeeping of

(b) marihuana, cannabis oil or a substance referred to in paragraph 22(3)(c), when transporting it to a port of exit from Canada and when transporting it between the port of entry into Canada and the producer’s site.

Marginal note:Report of loss or theft

29 If a licensed producer experiences a theft of cannabis or an unusual waste or disappearance of cannabis that cannot be explained on the basis of normally accepted business activities, the licensed producer must

(a) report the occurrence to a member of a police force within 24 hours after becoming aware of it; and

(b) provide a written report to the Minister within 10 days after becoming aware of the occurrence.

(i) conforms with all federal, provincial and municipal environmental legislation applicable to the location at which it is to be destroyed, and

(ii) does not result in any person being exposed to cannabis smoke; and

(b) in the presence of at least two persons who are qualified to witness the destruction, one of whom must be a person referred to in paragraph (2)(a).

Marginal note:Witness to destruction

(2) The following persons are qualified to witness the destruction of cannabis:

(a) the senior person in charge, the responsible person in charge and, if applicable, the alternate responsible person in charge; and

(b) a person who works for or provides services to the licensed producer and acts in a senior position.

Marginal note:Transportation of cannabis

(3) If the cannabis is to be destroyed at a location other than the licensed producer’s site, the senior person in charge, the responsible person in charge or, if applicable, the alternate responsible person in charge must accompany the cannabis to the location at which it is to be destroyed.

SUBDIVISION BLicensing

Marginal note:Eligible persons

31 The following persons are eligible to apply for a producer’s licence:

(a) one senior person in charge to have overall responsibility for management of the activities conducted by the licensed producer under their licence at their site — who may, if appropriate, be the licensed producer; and

(b) one responsible person in charge to work at the licensed producer’s site and have responsibility for supervising the activities with respect to cannabis conducted by the licensed producer under their licence at that site and for ensuring that the activities comply with the Act and its regulations and the Food and Drugs Act — who may, if appropriate, be the senior person in charge.

Marginal note:Alternate responsible person in charge

(2) A licensed producer may designate one or more alternate responsible persons in charge to work at the licensed producer’s site and have authority to replace the responsible person in charge when that person is absent.

Marginal note:Eligibility

(3) The senior person in charge, the responsible person in charge and, if applicable, the alternate responsible person in charge

(i) an individual, the individual’s name, date of birth and gender and any other name registered with a province, under which the individual intends to identify themself or conduct the activities for which the licence is sought (referred to in this section as the proposed activities), or

(ii) a corporation, its corporate name and any other name registered with a province, under which it intends to identify itself or conduct the proposed activities, as well as the name, date of birth and gender of each of its officers and directors;

(b) the address, telephone number and, if applicable, the facsimile number and email address for

(i) the site for which the licence is sought (referred to in this section as the proposed site), and

(ii) if applicable, each building within the site where the proposed activities are to be conducted;

(c) the mailing address for the proposed site and, if applicable, for each building referred to in subparagraph (b)(ii), if different from the address provided under paragraph (b);

(d) the name, date of birth and gender of each of the following persons:

(iii) if applicable, the proposed alternate responsible person in charge;

(e) the name and gender of each of the persons authorized to place an order for cannabis on behalf of the applicant;

(f) the activities among those referred to in subsection 22(1) that are proposed to be conducted, the purposes for conducting those activities and the substances in respect of which each of the activities is to be conducted;

(g) the proposed activities that are to be conducted at each building referred to in subparagraph (b)(ii) and the substances in respect of which each of those activities is to be conducted at each building;

(h) a detailed description of the security measures at the proposed site, as determined in accordance with the Security Directive and Subdivision C;

(i) a detailed description of the method that the applicant proposes to use for keeping records, which must permit

(ii) the Minister to audit the activities of the licensed producer with respect to cannabis, and

(iii) the reconciliation of orders for cannabis and shipments and inventories of cannabis;

(j) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and the substance referred to in paragraph 22(3)(b) to be produced by the applicant under the licence and the production period;

(k) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and marihuana seeds to be sold or provided by the applicant under the licence under subsections 22(2), (4) and (5) and the period in which that quantity is to be sold or provided; and

(l) if applicable, the maximum number of marihuana plants to be sold or provided by the applicant under the licence under subsections 22(2) and (5) and the period in which that quantity is to be sold or provided.

Marginal note:Dried marihuana equivalency factor

(2) In the case of an application for a licence to sell or provide fresh marihuana or cannabis oil under subsection 22(4), the applicant must provide the Minister, before commencing to sell or provide the substance, with the dried marihuana equivalency factor determined under section 79 and the method that they used to determine it.

Marginal note:Multiple sites

(3) If the applicant intends to conduct an activity referred to in subsection 22(1) at more than one site, a separate application must be submitted for each proposed site.

(a) a declaration, signed and dated by the proposed senior person in charge, stating that the proposed senior person in charge, the proposed responsible person in charge and, if applicable, the proposed alternate responsible person in charge are familiar with the provisions of the Act and its regulations and the Food and Drugs Act that will apply to the licence;

(b) if applicable, a copy of any document filed with the province in which the proposed site is located that states the applicant’s name and any other name registered with the province under which the applicant intends to identify themself or conduct the proposed activities;

(c) if the applicant is a corporation, a copy of the certificate of incorporation or other incorporating instrument;

(d) a declaration signed and dated by the proposed senior person in charge indicating whether or not the applicant is the owner of the entire proposed site;

(e) if the proposed site or any portion of it is not owned by the applicant, a declaration signed and dated by the owner of the site or each portion of the site consenting to the use of it by the applicant for the proposed activities;

(f) a declaration signed and dated by the proposed senior person in charge stating that the proposed site is not a dwelling place;

(g) a declaration signed and dated by the proposed senior person in charge stating that the notices to local authorities have been provided in accordance with section 48 and specifying the names, titles and addresses of the senior officials to whom they were addressed and the dates on which they were provided, together with a copy of each notice;

(h) a document signed and dated by the quality assurance person referred to in section 75 that includes

(i) a description of the person’s qualifications in respect of the matters referred to in subparagraph 75(1)(a)(ii), and

(ii) a report establishing that the buildings, equipment and sanitation program to be used in conducting the proposed activities referred to in Subdivision D comply with the requirements of that Subdivision; and

(d) if a producer’s licence is issued to an individual, that individual; and

(e) if a producer’s licence is issued to a corporation, each officer and director of the corporation.

Marginal note:Issuance of licence

35 Subject to section 36, the Minister must, after examining the information and documents required under section 33 and, if applicable, section 11, and after all of the security clearances required by section 34 have been granted under section 112, issue to the applicant a producer’s licence that indicates

(h) the expiry date of the licence, which must not be later than three years after its effective date;

(i) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and the substance referred to in paragraph 22(3)(b) that may be produced under the licence in a specified period;

(j) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and marihuana seeds that may be sold or provided under the licence in a specified period in accordance with subsections 22(2), (4) and (5);

(k) if applicable, the maximum number of marihuana plants that may be sold or provided under the licence in a specified period in accordance with subsections 22(2) and (5); and

(l) if applicable, any conditions that the licence holder must meet in order to

(c) an inspector, who has requested an inspection, has not been given the opportunity by the applicant to conduct an inspection under section 21;

(d) the Minister has reasonable grounds to believe that false or misleading information was submitted in, or false or falsified documents were submitted with, the application;

(e) information received from a peace officer, a competent authority or the United Nations raises reasonable grounds to believe that the applicant has been involved in the diversion of a controlled substance or precursor to an illicit market or use;

(f) the applicant does not have in place the security measures set out in the Security Directive and Subdivision C in respect of an activity for which the licence is sought;

(g) the applicant is in contravention of or has contravened in the past 10 years

(v) if the applicant is a corporation, any of its officers or directors;

(j) the proposed method of record keeping does not meet the requirements of paragraph 33(1)(i); or

(k) if applicable, the information required under section 11 has not been provided or is insufficient to process the application.

Marginal note:Exception

(2) Unless it is necessary to do so to protect public health, safety or security, including preventing cannabis from being diverted to an illicit market or use, the Minister must not refuse to issue, renew or amend a licence under paragraph (1)(d) or (g) if the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.

Marginal note:Failure to comply with undertaking

(3) If an applicant fails to comply with an undertaking referred to in subsection (2), the Minister must refuse to issue, renew or amend the licence.

(A) the information shown on the producer’s licence as specified in paragraphs 35(a) to (f ) and (i) to (l) is correct and complete, and

(B) if applicable, the requirements of sections 40 and 41 have been met.

Marginal note:Renewal

(2) Subject to section 36, the Minister must, after examining the information and documents required under subsection (1) and, if applicable, section 11, issue a renewed licence that contains the information set out in paragraphs 35(a) to (l).

Marginal note:Simultaneous processing of applications

(3) If a licensed producer submits an application under section 39 or paragraph 40(1)(a) together with an application under subsection (1), the Minister may process them together.

Marginal note:Amendment application

39(1) A licensed producer proposing to amend the content of their licence must provide the Minister with the following documents:

(a) an application in writing describing the proposed amendment, as well as any information or documents mentioned in section 33 that are relevant to the proposed amendment;

(b) if applicable, a declaration signed and dated by the senior person in charge stating that the notices to local authorities have been provided in accordance with section 49 and specifying the names, titles and addresses of the senior officials to whom they were addressed and the dates on which they were provided, together with a copy of each notice; and

(3) Subject to section 36, the Minister must, after examining the information and documents required under this section and, if applicable, section 11, amend the licence accordingly and may add any conditions that the licence holder must meet in order to

(ii) the responsible person in charge and, if applicable, the alternate responsible person in charge,

(iii) if applicable, an officer or director referred to in subparagraph 33(1)(a)(ii), or

(iv) an individual authorized to place an order for cannabis on behalf of the licensed producer;

(b) except in the case referred to in subsection (3), notify the Minister, not later than five days after the event, when a person referred to in any of subparagraphs (a)(i), (ii) and (iv) ceases to carry out their duties; and

(c) notify the Minister, not later than five days after the event, when a person referred to in subparagraph (a)(iii) ceases to be an officer or director.

Marginal note:Accompanying information

(2) The licensed producer must, with the application for approval referred to in paragraph (1)(a), provide the Minister with the following information and documents with respect to the new person:

(a) in the case of the replacement of the senior person in charge or the responsible person in charge or the replacement or addition of an alternate responsible person in charge,

(b) in the case of the replacement or addition of an officer or director, the information specified in subparagraph 33(1)(a)(ii) concerning that person; and

(c) in the case of the replacement or addition of an individual who is authorized to place an order for cannabis on behalf of the licensed producer, the information specified in paragraph 33(1)(e).

Marginal note:Notice to Minister — responsible person in charge

(3) A licensed producer must notify the Minister not later than the next business day if the responsible person in charge ceases to carry out their duties and there is no person designated as an alternate responsible person in charge.

Marginal note:Notice to Minister — various changes

41(1) A licensed producer must, within five days after the change, notify the Minister of any change to

(ii) if applicable, each building within the site where the activities are conducted under the licence; or

(c) the security of their site, other than a change that affects the security level of any location within the site where cannabis, other than marihuana plants, is stored.

Marginal note:Dried marihuana equivalency factor

(2) A licensed producer must provide the Minister with any new dried marihuana equivalency factor determined under section 79, and the method used to determine it, at least 10 days before selling or providing, under subsection 22(4), fresh marihuana or cannabis oil in respect of which the label referred to in section 84 or 88 indicates the new factor.

Marginal note:Statement by signatory of notice

42 An application or notification made under section 40 or 41, respectively, must

43(1) The Minister must suspend a producer’s licence without prior notice in respect of any or all activities or substances set out in the licence if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health, safety or security, including preventing cannabis from being diverted to an illicit market or use.

Marginal note:Notice of suspension

(2) The suspension takes effect as soon as the Minister notifies the licensed producer of the decision to suspend and provides a written report that sets out the reasons for the suspension.

Marginal note:Opportunity to be heard

(3) The licensed producer may, within 10 days after receipt of the notice, provide the Minister with reasons why the suspension is unfounded.

Marginal note:Ceasing of suspended activities

(4) If a licence is suspended in respect of any or all activities or substances set out in the licence, the licensed producer must cease conducting those activities with respect to those substances for the duration of the suspension.

Marginal note:Reinstatement of licence

(5) The Minister must, by notice to the licensed producer, reinstate a licence, in respect of any or all activities or substances affected by the suspension, if the licensed producer demonstrates to the Minister that

(a) the failure that gave rise to the suspension has been rectified; or

44 The Minister must revoke a licence if the licensed producer fails to comply with the decision of the Minister to suspend the licence under section 43 or if the failure that gave rise to the suspension is not rectified.

Marginal note:Revocation — lost or stolen licence

45 The Minister must revoke a producer’s licence on being notified by the licensed producer that the licence has been lost or stolen.

Marginal note:Revocation — other grounds

46(1) Subject to subsection (2), the Minister must revoke a producer’s licence in the following circumstances:

(a) the Minister has reasonable grounds to believe that the licence was issued on the basis of false or misleading information submitted in, or false or falsified documents submitted with, the application;

(b) the licensed producer has, since the issuance of the licence, contravened a provision of the Act or its regulations or the Food and Drugs Act or a condition of their licence or of an import or export permit issued under this Part;

(d) information received from a peace officer, a competent authority or the United Nations raises reasonable grounds to believe that the licensed producer has been involved in the diversion of a controlled substance or precursor to an illicit market or use; or

(e) any of the persons referred to in section 34 does not hold a security clearance.

Marginal note:Exceptions

(2) Unless it is necessary to do so to protect public health, safety or security, including preventing cannabis from being diverted to an illicit market or use, the Minister must not revoke a producer’s licence in the circumstances described in paragraph (1)(a) or (b) if the licensed producer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.

Marginal note:Failure to comply with undertaking

(3) If the licensed producer fails to comply with an undertaking referred to in subsection (2), the Minister must revoke the licence.

Marginal note:Notice of cessation of activities

47(1) A licensed producer who intends to cease conducting activities at their site — whether before or on the expiry of their licence — must submit to the Minister a written notice to that effect at least 30 days before ceasing those activities.

Marginal note:Content of notice

(2) The notice must be signed and dated by the senior person in charge and contain the following information:

(b) a description of the manner in which any cannabis remaining on the site as of the date referred to in paragraph (a) will be dealt with by the licensed producer, including

(i) if some or all of it will be sold or provided to another licensed producer who will be conducting activities at the same site, the name of that producer,

(ii) if some or all of it will be sold or provided to another licensed producer or a licensed dealer, the name of that producer and the address of their site or the name of that dealer and the address of their premises, and

(iii) if some or all of it will be destroyed, the date on which and the location at which the destruction is to take place;

(c) the address of the location at which the licensed producer’s records, books, electronic data and other documents will be kept after activities have ceased; and

(d) the name, address, telephone number and, if applicable, the facsimile number and email address of a person whom the Minister may contact for further information after activities have ceased.

Marginal note:Update

(3) After having ceased the activities, the licensed producer must submit to the Minister a detailed update of the information referred to in paragraphs (2)(a) to (d), if it differs from what was set out in the notice submitted under subsection (1). The update must be signed and dated by the senior person in charge.

Marginal note:Return and revocation of licence

(4) If the activities cease before the expiry of the licence, the licensed producer must return to the Minister the original of the licence. The Minister must then revoke the licence.

Marginal note:Notice to local authorities – licence application

48(1) Before submitting an application for a producer’s licence to the Minister under section 33, the applicant must provide a written notice to the following authorities in the area in which the site referred to in paragraph 33(1)(b) is located:

(c) a band that is a party to a comprehensive self-government agreement given effect by an Act of Parliament.

Marginal note:Notice to local authorities — amendment application

49(1) Before submitting a licence amendment application to the Minister under section 39 concerning a change referred to in subsection (2), a licensed producer must provide a written notice to the authorities referred to in paragraphs 48(1)(a) to (c) in the area in which the site to be specified in the amended licence is located.

Marginal note:Applicable changes

(2) Subsection (1) applies in respect of an application to amend a licence to change

(a) the name of the licensed producer and, if applicable, the proposed new name of the producer;

(b) the date on which the producer will submit the application to the Minister;

(c) the activities referred to in subsection 22(1) that are to be set out in the amended licence, specifying that they are to be conducted in respect of cannabis; and

(d) the address of the site and, if applicable, of each building within the site that is to be set out in the amended licence.

Marginal note:Senior official

(4) The notice must be addressed to a senior official of the local authority to whom it is provided.

Marginal note:Notice to local authorities — various matters

50(1) Within 30 days after the issuance, renewal, amendment, suspension, reinstatement or revocation of its licence, a licensed producer must provide a written notice to the local authorities referred to in paragraphs 48(1)(a) to (c) in the area in which the site specified in the licence is located and provide a copy of the notice to the Minister.

(a) the name of the licensed producer and the address of their site; and

(b) a description of the applicable event referred to in subsection (1) and its effective date and, in the case of an amendment to the licence, details of the amendment.

Marginal note:Senior official

(3) The notice must be addressed to a senior official of the local authority to whom it is provided.

Marginal note:Notice to licensing authorities

51(1) Within 30 days after the issuance of its licence, a licensed producer must provide a written notice to each licensing authority that is responsible for the registration or authorization of persons to practise medicine or nursing in each province and provide a copy of the notice to the Minister.

SUBDIVISION CSecurity Measures

General

52 A licensed producer must ensure that the security measures set out in this Subdivision are carried out.

Marginal note:Unauthorized access

53 The licensed producer’s site must be designed in a manner that prevents unauthorized access.

Perimeter of Site

Marginal note:Visual monitoring

54(1) The perimeter of the licensed producer’s site must be visually monitored at all times by visual recording devices to detect any attempted or actual unauthorized access.

Marginal note:Visual recording devices

(2) The devices must, in the conditions under which they are used, be capable of making a visible recording of any attempted or actual unauthorized access.

Marginal note:Intrusion detection system

55 The perimeter of the licensed producer’s site must be secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to or movement in the site or tampering with the system.

Marginal note:Monitoring by personnel

56(1) The intrusion detection system must be monitored at all times by personnel who must determine the appropriate steps to be taken in response to the detection of any occurrence referred to in section 54 or 55.

Marginal note:Record of detected occurrences

(2) If any such occurrence is detected, the personnel must make a record of

(b) the measures taken in response to it and the date and time when they were taken.

Areas Within a Site Where Cannabis is Present

Marginal note:Restricted access

57(1) Access to areas within a site where cannabis is present (referred to in this section and sections 58 to 61 as those areas) must be restricted to persons whose presence in those areas is required by their work responsibilities.

Marginal note:Responsible person in charge present

(2) The responsible person in charge or, if applicable, the alternate responsible person in charge must be physically present while other persons are in those areas.

Marginal note:Record

(3) A record must be made of the identity of every person entering or exiting those areas.

Marginal note:Physical barriers

58 Those areas must include physical barriers that prevent unauthorized access.

Marginal note:Visual monitoring

59(1) Those areas must be visually monitored at all times by visual recording devices to detect illicit conduct.

Marginal note:Visual recording devices

(2) The devices must, in the conditions under which they are used, be capable of making a visible recording of illicit conduct.

Marginal note:Intrusion detection system

60 Those areas must be secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to or movement in those areas or tampering with the system.

Marginal note:Filtration of air

61 Those areas must be equipped with a system that filters air to prevent the escape of odours and, if present, pollen.

Marginal note:Monitoring by personnel

62(1) The intrusion detection system must be monitored at all times by personnel who must determine the appropriate steps to be taken in response to the detection of any occurrence referred to in section 59 or 60.

Marginal note:Record of detected occurrences

(2) If any such occurrence is detected, the personnel must make a record of

(b) the measures taken in response to it and the date and time when they were taken.

SUBDIVISION DGood Production Practices

Marginal note:Prohibition — sale, provision or export

63(1) A licensed producer must not sell or provide fresh or dried marihuana, cannabis oil or marihuana plants or seeds under subsection 22(4) or (5) or export them, if applicable, unless the applicable requirements of this Subdivision have been met.

Marginal note:Research and development activity

(2) A licensed producer must not sell or provide those substances under subsection 22(4) or (5) if they have been used in research and development activity.

Marginal note:Microbial and chemical contaminants

64 The microbial and chemical contaminants of fresh or dried marihuana or cannabis oil must be within generally accepted tolerance limits for herbal medicines for human consumption, as established in any publication referred to in Schedule B to the Food and Drugs Act.

Marginal note:Disintegration of capsule

65 A capsule or similar dosage form of cannabis oil that is intended to be swallowed whole or used as a suppository must meet the requirements of a disintegration test that is applicable to the formulation of the capsule or similar dosage form and that is set out in any publication referred to in Schedule B to the Food and Drugs Act.

Marginal note:Pest control product

66 Fresh or dried marihuana or marihuana plants or seeds must not be treated with a pest control product unless the product is registered for use on marihuana under the Pest Control Products Act or is otherwise authorized for use under that Act.

Marginal note:Maximum yield quantity — cannabis oil

67(1) Cannabis oil must not exceed a maximum yield quantity of 30 mg of delta-9-tetrahydrocannabinol per millilitre of the oil in the immediate container, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol.

Marginal note:Capsule or other dosage form

(2) If cannabis oil is in a capsule or similar dosage form, each capsule or unit of the dosage form must not exceed a maximum yield quantity of 10 mg of delta-9-tetrahydrocannabinol, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol.

Marginal note:Solvents

68(1) Cannabis oil must not contain residues of solvents other than Class 3 solvents listed in the Guidance Document — Impurities: Guideline for Residual Solvents, ICH Topic Q3C(R5), published by the Department of Health, as amended from time to time.

Marginal note:Residue limit

(2) Those residues must not exceed the limits established under that document.

70(1) Fresh or dried marihuana, cannabis oil or marihuana plants or seeds must be produced, packaged, labelled and stored in premises that are designed, constructed and maintained in a manner that permits those activities to be conducted under sanitary conditions, and in particular that

(e) prevents the addition of an extraneous substance to the substance.

Marginal note:Storage

(2) Those substances must be stored under conditions that will maintain their quality.

Marginal note:Equipment

71 Fresh or dried marihuana, cannabis oil or marihuana plants or seeds must be produced, packaged, labelled and stored using equipment that is designed, constructed, maintained, operated and arranged in a manner that

(d) prevents the addition of an extraneous substance to the substance.

Marginal note:Sanitation program

72 Fresh or dried marihuana, cannabis oil or marihuana plants or seeds must be produced, packaged, labelled and stored in accordance with a sanitation program that sets out

(a) procedures for effectively cleaning the premises in which those activities are conducted;

(b) procedures for effectively cleaning the equipment used in those activities;

(c) procedures for handling any substance used in those activities; and

(d) all requirements, in respect of the health, hygienic behaviour and clothing of the personnel who are involved in those activities, that are necessary to ensure that those activities are conducted in sanitary conditions.

Marginal note:Standard operating procedures

73 Fresh or dried marihuana, cannabis oil or marihuana plants or seeds must be produced, packaged, labelled and stored in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the requirements of this Subdivision.

Marginal note:Recall

74 A licensed producer must establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds that has been made available for sale.

(i) is responsible for assuring the quality of the fresh or dried marihuana, cannabis oil or marihuana plants or seeds before they are made available for sale, and

(ii) has the training, experience and technical knowledge relating to the activity conducted and the requirements of this Subdivision; and

(b) investigate every complaint received in respect of the quality of those substances and, if necessary, take corrective and preventative measures.

Marginal note:Methods and procedures

(2) Those substances must be produced, packaged, labelled and stored using methods and procedures that, prior to their implementation, have been approved by a quality assurance person.

Marginal note:Approval prior to sale

(3) Every lot or batch of those substances must be approved by a quality assurance person before it is made available for sale.

Marginal note:Returns

(4) Any of those substances that is sold or provided under subsection 22(4) or (5) and subsequently returned to the licensed producer must not be resold or provided again.

Marginal note:Sample of lot or batch

76(1) Subject to subsection (3), if the Minister has reasonable grounds to believe that a lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds made available for sale or provision by a licensed producer may — by reason of the manner in which the substance was produced, packaged, labelled or stored — pose a risk to the health of a person who obtains the substance for their own medical purposes, the Minister may require the licensed producer to provide the Minister with a sample of that lot or batch.

Marginal note:Quantity

(2) The sample must be of sufficient quantity to enable a determination of whether the lot or batch meets the requirements of sections 64 and 66 and, if applicable, sections 65, 67 and 68.

Marginal note:Period

(3) The Minister must not require a sample to be provided if more than one year has elapsed after the date of the last sale or provision of any portion of the lot or batch.

Marginal note:Recall reporting

77 Before commencing a recall of fresh or dried marihuana, cannabis oil or marihuana plants or seeds, a licensed producer must provide the Minister with the following information in respect of the substance to be recalled:

(e) the quantity that was produced or imported into Canada by the licensed producer;

(f) the quantity that was sold or provided in Canada by the licensed producer;

(g) the quantity remaining in the possession of the licensed producer;

(h) the number of persons referred to in subsections 22(2), (4) and (5) to whom it was sold or provided by the licensed producer; and

(i) a description of any other action that the licensed producer is taking in respect of the recall.

Marginal note:Adverse reactions

78(1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil must provide the Minister with a case report for each serious adverse reaction to the substance, within 15 days after the day on which the producer becomes aware of the reaction.

Marginal note:Summary report

(2) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil must prepare annually and maintain a summary report that contains a concise and critical analysis of all adverse reactions to the substance that have occurred during the previous 12 months.

Marginal note:Provide Minister with report on request

(3) If, after reviewing a case report provided under subsection (1) or after reviewing any other safety data relating to the fresh or dried marihuana or cannabis oil, the Minister has reasonable grounds to believe that it may — by reason of the manner in which it was produced, packaged, labelled or stored — pose a risk to the health of a person who in accordance with these Regulations obtains it for their own medical purposes, the Minister may request that, within 30 days after the day on which the request is received, the licensed producer

(a) provide the Minister with a copy of any summary report prepared under subsection (2); or

(b) prepare and provide the Minister with an interim summary report containing a concise and critical analysis of all adverse reactions to the substance that have occurred since the date of the most recent summary report prepared under subsection (2).

case report means a detailed record of all relevant data associated with the use of fresh or dried marihuana or cannabis oil by a person. (fiche d’observation)

serious adverse reaction

serious adverse reaction means a noxious and unintended response to fresh or dried marihuana or cannabis oil that requires in-patient hospitalization or a prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave)

SUBDIVISION EDried Marihuana Equivalency Factor

Marginal note:Equivalency factor

79(1) A licensed producer who sells or provides fresh marihuana or cannabis oil under subsection 22(4) must determine the quantity of the marihuana or oil that is equivalent to one gram of dried marihuana.

Marginal note:Information

(2) The information about the dried marihuana equivalency factor must be made available on the licensed producer’s website and be provided on request.

SUBDIVISION FPackaging, Labelling and Shipping

Marginal note:Packaging

80(1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) must ensure that

(c) has a security feature that provides reasonable assurance to consumers that the container has not been opened prior to receipt.

Marginal note:Marihuana plants

(3) A licensed producer who sells or provides marihuana plants under subsection 22(5) must ensure that they are sold or provided in a package that has a security feature that provides reasonable assurance to consumers that the package has not been opened prior to receipt.

Marginal note:Accuracy of weight

81(1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) must ensure that the net weight of the substance in the immediate container is not less than 95% and not more than 105% of the net weight specified on the label in accordance with section 84.

Marginal note:Accuracy of volume

(2) A licensed producer who sells or provides cannabis oil under subsection 22(4) must ensure that the net volume of the oil in the immediate container is not less than 95% and not more than 105% of the net volume specified on the label in accordance with section 84.

Marginal note:Accuracy — number of capsules or units

(3) A licensed producer who sells or provides cannabis oil under subsection 22(4) in a capsule or similar dosage form must ensure that number of capsules or units in the container is the same as the number specified on the label in accordance with section 84.

Marginal note:Accuracy — number of seeds

82 A licensed producer who sells or provides marihuana seeds under subsection 22(5) must ensure that the number of seeds in the immediate container is the same as the number specified on the label in accordance with section 85.

Marginal note:Accuracy — number of plants

83 A licensed producer who sells or provides marihuana plants under subsection 22(5) must ensure that the exact number of plants in the package referred to in subsection 80(3) is indicated on the package.

Marginal note:Product label — marihuana or cannabis oil

84(1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) must ensure that a label that contains the following information and the information set out in subsection (2), (3) or (4), as applicable, is affixed to the immediate container:

(a) the name, telephone number and email address of the licensed producer;

(b) the percentage of delta-9-tetrahydrocannabinol w/w, followed by the word “delta-9-tetrahydrocannabinol”;

(c) the percentage of delta-9-tetrahydrocannabinol w/w that the marihuana could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol;

(d) the percentage of cannabidiol w/w, followed by the word “cannabidiol”;

(e) the percentage of cannabidiol w/w that the marihuana could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol; and

(f) in the case of fresh marihuana, the dried marihuana equivalency factor determined under section 79.

Marginal note:Oil other than in dosage form

(3) In the case of cannabis oil that is not sold in a capsule or similar dosage form, the label must also contain the following information in respect of the oil in the container:

(c) the quantity of delta-9-tetrahydrocannabinol, in milligrams per millilitre;

(d) the quantity of delta-9-tetrahydrocannabinol, in milligrams per millilitre, that the oil could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol;

(b) the net weight in grams as well as the net volume in millilitres of each capsule or unit;

(c) the quantity of delta-9-tetrahydrocannabinol, in milligrams, in each capsule or unit;

(d) the quantity of delta-9-tetrahydrocannabinol, in milligrams, that each capsule or unit could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol;

(e) the quantity of cannabidiol, in milligrams, in each capsule or unit;

(f) the quantity of cannabidiol, in milligrams, that each capsule or unit could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol;

(b) a separate document containing the information referred to in paragraph (a) accompanies each shipment of the substance.

Marginal note:Marihuana seeds

(2) A licensed producer who sells or provides marihuana seeds under subsection 22(5) to a client or an individual who is responsible for the client must ensure that a label that contains the following information is affixed to the immediate container:

(3) A licensed producer who sells or provides marihuana plants under subsection 22(5) to a client or an individual who is responsible for the client must ensure that the package referred to in subsection 80(3) or each plant bears a label that contains the following information:

88 In the case of fresh or dried marihuana, cannabis oil or marihuana plants or seeds to be sold or provided to a client or an individual who is responsible for the client, the information required under section 84, 85 or 86 and under paragraph 87(1)(a) or subsection 87(2) or (3), as applicable, may be set out on one label.

SOR/2017-18, s. 26

Marginal note:Department of Health document

89 A licensed producer who sells or provides fresh or dried marihuana, cannabis oil or marihuana plants or seeds under subsection 22(4) or (5) must ensure that each shipment of the substance is accompanied by a copy of the current version of the document entitled Consumer Information — Cannabis (Marihuana, marijuana), published by the Department of Health.

Marginal note:Presentation of information — label

90(1) All information that is required under section 84, 85 or 86 and under paragraph 87(1)(a) or subsection 87(2) or (3), as applicable, to appear on a label must be

(2) All information in a document that is required under paragraph 87(1)(b) or section 89 must be in English and in French and readily discernible under the customary conditions of use.

SOR/2017-18, s. 27

Marginal note:Expiry date

91(1) A licensed producer must not include an expiry date on a label referred to in section 84 unless

(a) the licensed producer has submitted data to the Minister that establishes the stability period during which, after the fresh or dried marihuana or cannabis oil is packaged in accordance with section 80 and when it is stored under its recommended storage conditions referred to in subparagraph 84(1)(c)(iii),

(i) the substance maintains not less than 80% and not more than 120% of its delta-9-tetrahydrocannabinol content and cannabidiol content, and

(ii) the microbial and chemical contaminants of the substance remain within the limits referred to in section 64; and

(b) in the Minister’s opinion the data submitted by the licensed producer meets the requirements of paragraph (a) and the Minister has notified the producer to that effect.

Definition of expiry date

(2) For the purposes of subsection (1) and subparagraph 84(1)(c)(v), expiry date means the date, expressed at minimum as a year and month, that is the end of the stability period.

Marginal note:Reference to Acts or regulations

92 It is prohibited to include a reference, direct or indirect, to the Act, the Food and Drugs Act or any regulations made under those Acts on a label of or in an advertisement for fresh or dried marihuana, cannabis oil or marihuana plants or seeds unless the reference is a specific requirement of either of those Acts or those regulations.

Marginal note:Shipping

93(1) A licensed producer who ships fresh or dried marihuana or cannabis oil to a person referred to in subsection 22(2) or (4), or who ships a substance referred to in paragraph 22(3)(b) to a person referred to in subsection 22(2), must

(i) in the case of a person referred to in subsection 22(2), the shipping address indicated in the order referred to in section 149; and

(ii) in the case of a person referred to in subsection 22(5), the address of the site for the production of marihuana plants or the site for the storage of cannabis that is specified in the person’s registration with the Minister made under Part 2.

Marginal note:Marihuana plants

(3) A licensed producer who ships marihuana plants to a person referred to in subsection 22(2) or (5) must

(a) prepare the package in a manner that ensures the security of its contents, such that

(i) it will not open or permit the escape of its contents during handling and transportation,

(ii) it is sealed so that it cannot be opened without the seal being broken, and

(iii) it prevents its contents from being identified without it being opened;

(a) be signed and dated by the responsible person in charge or, if applicable, the alternate responsible person in charge at the licensed producer’s site; and

(b) include a statement, signed and dated by that person, indicating that all information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

Marginal note:Issuance of import permit

95(1) Subject to section 96, the Minister must, after examining the information and documents required under section 94 and, if applicable, section 11, issue to the licensed producer an import permit that indicates

(a) its expiry date or the date on which it is suspended or revoked under section 100 or 101, respectively,

(b) the expiry date of the producer’s licence to which the permit pertains or the date on which that licence is suspended or revoked, and

(c) the expiry date of the export permit that applies to the substance to be imported and that is issued by a competent authority in the country of export or the date on which that permit is suspended or revoked.

Marginal note:Validity

(3) A permit issued under this section is valid only for the importation in respect of which it is issued.

(a) in respect of the application for the permit, there exists a circumstance described in paragraph 36(1)(d), (e), (f) or (h), with any modifications that the circumstances require;

(b) the applicant does not hold a producer’s licence with respect to the substance that is to be imported;

(c) the applicant has been notified that one of the following applications submitted by the applicant in respect of the producer’s licence to which the requested permit pertains is to be refused under section 36:

(i) the shipment for which the permit is requested would contravene the laws of the country of export or any country of transit or transhipment, or

(ii) the importation is for the purpose of re-exporting the substance.

Marginal note:Provision of copy of import permit

97 On request of a customs officer, the holder of an import permit must provide a copy of the permit to the customs office, sufferance warehouse or bonded warehouse, as the case may be, at the port of entry into Canada at the time of importation.

Marginal note:Declaration after release from customs

98 The holder of an import permit must provide the Minister, within 15 days after the day of release, in accordance with the Customs Act, of a shipment that contains the imported substance, with a declaration that contains the following information:

(a) the name of the licensed producer and the numbers of the producer’s licence and import permit in respect of the shipment;

(v) in the case of dried marihuana, its percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w.

Marginal note:Transportation of imported substance

99 The holder of an import permit must ensure that, after the imported substance is released, it is transported directly to the site specified in their producer’s licence.

Marginal note:Suspension of import permit

100(1) The Minister must suspend an import permit without prior notice if

(a) the Minister has reasonable grounds to believe that it is necessary to do so to protect public health, safety or security, including preventing the imported substance from being diverted to an illicit market or use; or

(b) the importation would contravene the laws of any country of transit or transhipment.

Marginal note:Notice of suspension

(2) The suspension takes effect as soon as the Minister notifies the permit holder of the decision to suspend and provides a written report that sets out the reasons for the suspension.

Marginal note:Opportunity to be heard

(3) The permit holder may, within 10 days after receipt of the notice, provide the Minister with reasons why the suspension is unfounded.

(2) Subject to subsection (3), the Minister must revoke an import permit in the following circumstances:

(a) there exists a circumstance described in any of paragraphs 46(1)(a) to (e) in respect of the producer’s licence to which the permit pertains;

(b) the Minister has reasonable grounds to believe that the import permit was issued on the basis of false or misleading information submitted in, or false or falsified documents submitted with, the application for the permit; or

(c) the importation is for the purpose of re-exporting the imported substance.

Marginal note:Exceptions

(3) Unless it is necessary to do so to protect public health, safety or security, including preventing the imported substance from being diverted to an illicit market or use, the Minister must not revoke an import permit in the circumstances described in paragraph (2)(b) or 46(1)(a) or (b) if the permit holder has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.

Marginal note:Failure to comply with undertaking

(4) If the permit holder fails to comply with an undertaking mentioned in subsection (3), the Minister must revoke the permit.

Marginal note:Revocation following suspension

(5) The Minister must revoke a permit if the permit holder fails to comply with the suspension of the permit under section 100 or if the situation giving rise to the suspension is not rectified.

Marginal note:Application for export permit

102(1) To apply for a permit to export marihuana or a substance referred to in paragraph 22(3)(c), a licensed producer must submit the following information and declaration to the Minister:

(g) a declaration that, to the best of their knowledge, the shipment does not contravene the laws of the country of final destination or any country of transit or transhipment.

Marginal note:Accompanying document

(2) An application for an export permit must be accompanied by a copy of the import permit issued by a competent authority in the country of final destination that sets out the name and address of the site of the importer in the country of final destination.

(a) be signed and dated by the responsible person in charge or, if applicable, the alternate responsible person in charge at the licensed producer’s site; and

(b) include a statement, signed and dated by that person, indicating that all information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

Marginal note:Issuance of export permit

103(1) Subject to section 104, the Minister must, after examining the information and documents required under section 102 and, if applicable, section 11, issue an export permit to the licensed producer that indicates

(a) its expiry date or the date on which it is suspended or revoked under section 107 or 108, respectively,

(b) the expiry date of the producer’s licence to which the permit pertains or the date on which the that licence is suspended or revoked, and

(c) the expiry date of the import permit that applies to the substance to be exported and that is issued by a competent authority in the country of final destination or the date on which that permit is suspended or revoked.

Marginal note:Validity

(3) A permit issued under this section is valid only for the exportation in respect of which it is issued.

(a) in respect of the application for the permit, there exists a circumstance described in paragraph 36(1)(d), (e) or (h), with any modifications that the circumstances require;

(b) the applicant does not hold a producer’s licence in respect of the substance that is to be exported;

(c) the applicant has been notified that one of the following applications submitted by the applicant in respect of the producer’s licence to which the requested permit pertains is to be refused under section 36:

(ii) an application made under section 38 for the renewal of a producer’s licence, or

(iii) an application made under section 39 for the amendment of a producer’s licence;

(d) the Minister has reasonable grounds to believe that the shipment for which the permit is requested would contravene the laws of the country of final destination or any country of transit or transhipment; or

(e) the shipment would not be in conformity with the import permit issued by a competent authority of the country of final destination.

Marginal note:Provision of copy of export permit

105 On request of a customs officer, the holder of an export permit must provide a copy of the permit to the customs office, sufferance warehouse or bonded warehouse, as the case may be, at the port of exit from Canada at the time of exportation.

Marginal note:Declaration after export

106 The holder of an export permit must provide the Minister, within 15 days after the day on which a shipment of the substance is exported, with a declaration that contains the following information:

(a) the name of the licensed producer and the numbers of the producer’s licence and export permit in respect of the shipment;

(v) in the case of dried marihuana, its percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w.

Marginal note:Suspension of export permit

107(1) The Minister must suspend an export permit without prior notice if

(a) the Minister has reasonable grounds to believe that it is necessary to do so to protect public health, safety or security, including preventing the exported substance from being diverted to an illicit market or use;

(b) the exportation is not in conformity with an import permit issued by a competent authority of the country of final destination; or

(c) the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.

Marginal note:Notice of suspension

(2) The suspension takes effect as soon as the Minister notifies the permit holder of the decision to suspend and provides a written report that sets out the reasons for the suspension.

Marginal note:Opportunity to be heard

(3) The permit holder may, within 10 days after receipt of the notice, provide the Minister with reasons why the suspension is unfounded.

(2) Subject to subsection (3), the Minister must revoke an export permit in the following circumstances:

(a) there exists a circumstance described in any of paragraphs 46(1)(a) to (e) in respect of the producer’s licence to which the permit pertains; or

(b) the Minister has reasonable grounds to believe that the export permit was issued on the basis of false or misleading information submitted in, or false or falsified documents submitted with, the application.

Marginal note:Exceptions

(3) Unless it is necessary to do so to protect public health, safety or security, including preventing the exported substance from being diverted to an illicit market or use, the Minister must not revoke an export permit in the circumstances described in paragraph (2)(b) or 46(1)(a) or (b) if the permit holder has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.

Marginal note:Failure to comply with undertaking

(4) If the permit holder fails to comply with an undertaking mentioned in subsection (3), the Minister must revoke the permit.

Marginal note:Revocation following suspension

(5) The Minister must revoke a permit if the permit holder fails to comply with the suspension of the permit under section 107 or if the situation giving rise to the suspension is not rectified.

SUBDIVISION HSecurity Clearances

Marginal note:Eligibility

109 Only the following persons may submit to the Minister an application for a security clearance:

(c) if the applicant was born in Canada, the number and province of issue of their birth certificate;

(d) if the applicant was born outside Canada, their place of birth, the port and date of entry into Canada, and, in the case of a naturalized Canadian or permanent resident, the number of the applicable certificate issued under the Citizenship Act or the Immigration and Refugee Protection Act;

(i) a copy of a valid piece of photo identification of the applicant issued by the Government of Canada or the government of a province, or

(ii) a copy of the applicant’s passport that includes the passport number, country of issue and expiry date and the applicant’s photograph;

(f) the addresses of all locations at which the applicant resided during the five years preceding the application;

(g) an identification of the applicant’s activities during the five years preceding the application, including the names and addresses of the applicant’s employers and any post-secondary educational institutions attended;

(h) the dates, destination and purpose of any travel of more than 90 days outside Canada, excluding travel for government business, during the five years preceding the application;

(ii) any former spouses or common-law partners with whom the relationship ended within the five years preceding the application;

(j) the applicant’s fingerprints, taken by a Canadian police force or by a private company that is accredited by the Royal Canadian Mounted Police to submit fingerprints to it for the purpose of a criminal record check; and

(k) a declaration signed and dated by the licensed producer or the applicant for a producer’s licence stating that the applicant for the security clearance requires or will require a security clearance and specifying the reasons for that requirement.

Marginal note:Spouse or common-law partner

(2) The information required in respect of any of the persons referred to in paragraph (1)(i) is

(a) in the case of the applicant’s spouse or common-law partner, the following information:

(i) their gender, full given name, surname and, if applicable, maiden name,

(b) in the case of former spouses and common-law partners with whom the relationship ended within the five years preceding the application, the information referred to in subparagraphs (a)(i), (ii) and (v).

Marginal note:Signed by applicant

(3) The application for a security clearance must be signed and dated by the applicant.

Definition of common-law partner

(4) In this section, common-law partner means any person who is cohabiting with the applicant in a relationship of a conjugal nature and has done so for a period of at least one year.

Marginal note:Checks

111 On receipt of a fully completed application for a security clearance, the Minister must conduct the following checks for the purpose of assessing whether an applicant poses a risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use:

(b) a check of the relevant files of law enforcement agencies, including intelligence gathered for law enforcement purposes.

Marginal note:Minister’s decision

112 The Minister may grant a security clearance if, in the Minister’s opinion, the information provided by the applicant and that resulting from the checks is reliable and is sufficient for the Minister to determine, by taking into account the following factors, that the applicant does not pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use:

(i) has been convicted, as an adult, of a designated drug offence as defined in section 2 of the Narcotic Control Regulations or a designated criminal offence as defined in that section,

(ii) has been convicted, as an adult, of an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i),

(iii) has been convicted of an offence referred to in subparagraph (i) as a young person in ordinary court, as those terms were defined in subsection 2(1) of the Young Offenders Act, chapter Y-1 of the Revised Statutes of Canada, 1985, immediately before that Act was repealed,

(iv) has received an adult sentence as a young person, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act, in respect of an offence referred to in subparagraph (i), or

(v) has received a sentence — for an offence they committed outside Canada when they were at least 14 years old but less than 18 years old that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) — that was longer than the maximum youth sentence that could have been imposed under the Youth Criminal Justice Act for such an offence;

(b) whether it is known or there are reasonable grounds to suspect that the applicant

(i) is or has been involved in, or contributes or has contributed to, illicit activities directed toward or in support of the trafficking or diversion of controlled substances or precursors,

(ii) is or has been a member of a criminal organization as defined in subsection 467.1(1) of the Criminal Code, or participates or has participated in, or contributes or has contributed to, the activities of such an organization as referred to in subsection 467.11(1) of the Criminal Code,

(iii) is or has been a member of an organization that is known to be involved in or to contribute to — or in respect of which there are reasonable grounds to suspect involvement in or contribution to — activities directed toward or in support of the threat of or the use of acts of violence against persons or property, or is or has been involved in, or is contributing to or has contributed to, the activities of such an organization, or

(iv) is or has been associated with an individual who is known to be involved in or to contribute to — or in respect of whom there are reasonable grounds to suspect involvement in or contribution to — activities referred to in subparagraph (i), or is a member of an organization referred to in subparagraph (ii) or (iii);

(c) whether there are reasonable grounds to suspect that the applicant is in a position in which there is a risk that they be induced to commit an act or to aid or abet any person to commit an act that might constitute a risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use;

(e) whether the applicant has submitted false or misleading information in, or false or falsified documents with, their application for a security clearance.

Marginal note:Outstanding criminal charge

113 If there is an outstanding criminal charge against the applicant that could, if the applicant were convicted, be taken into account by the Minister under paragraph 112(a), the Minister may decline to process the application until the charge has been disposed of by the courts, in which case the Minister must notify the applicant in writing.

Marginal note:Refusal to grant security clearance

114(1) If the Minister intends to refuse to grant a security clearance, the Minister must notify the applicant in writing to that effect.

Marginal note:Content of notice

(2) The notice must set out the basis for the Minister’s intention and fix a period of time within which the applicant may make written representations to the Minister, which period of time must start on the day on which the notice is served or sent and must be not less than 20 days.

Marginal note:Opportunity to make written representations

(3) The Minister must not refuse to grant a security clearance until the written representations have been received and considered or before the period of time fixed in the notice has expired, whichever comes first. The Minister must notify the applicant in writing of any refusal.

Marginal note:Validity period

115(1) The Minister must establish a period of validity for a security clearance in accordance with the level of risk posed by the applicant as determined under section 112, but the period must not exceed five years.

Marginal note:Extension of period

(2) If the validity period is less than five years, the Minister may extend the period to a total of five years if the Minister determines under section 112 that the holder does not pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use.

Marginal note:Security clearance no longer required

116 A licensed producer must notify the Minister in writing not later than five days after the holder of a security clearance is no longer required under this Part to hold a security clearance. The Minister must then cancel the clearance.

Marginal note:Suspension of security clearance

117(1) The Minister may suspend a security clearance on receipt of information that could change the Minister’s determination made under section 112.

Marginal note:Written notice to holder

(2) Immediately after suspending a security clearance, the Minister must notify the holder in writing of the suspension.

Marginal note:Content of notice

(3) The notice must set out the basis for the suspension and fix a period of time within which the holder may make written representations to the Minister, which period of time must start on the day on which the notice is served or sent and must be not less than 20 days.

Marginal note:Reinstatement of clearance

(4) The Minister may reinstate the security clearance if the Minister determines under section 112 that the holder does not pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use.

Marginal note:Cancellation of clearance

(5) The Minister may cancel the security clearance if the Minister determines under section 112 that the holder may pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use. The Minister must notify the holder in writing of any cancellation.

Marginal note:Opportunity to be heard

(6) The Minister must not cancel the security clearance until the written representations referred to in subsection (3) have been received and considered or before the time period fixed in the notice referred to in that subsection has expired, whichever comes first.

Marginal note:New applications

118 If the Minister refuses to grant or cancels a security clearance, an applicant may submit a new application only if

(a) a period of five years has elapsed since the day on which the refusal or cancellation occurs; or

(b) a change has occurred in the circumstances that led to the refusal or cancellation.

Marginal note:Sending of notices by Minister

119 The Minister must send any notice to be given under this Subdivision to the person at their last known address by using a method of sending that involves

(c) the keeping of an accurate record of the signatures of any persons having charge of it until it is delivered.

Marginal note:False or misleading information

120 It is prohibited to knowingly submit to the Minister an application containing false or misleading information in order to obtain a security clearance.

SUBDIVISION ICommunication of Information

Marginal note:Information concerning clients

121(1) Subject to subsection (2), if a licensed producer is provided with the given name, surname, date of birth and gender of an individual by a member of a Canadian police force who requests information in the course of an investigation under the Act or these Regulations, the licensed producer must provide as soon as feasible, within 72 hours after receiving the request, the following information to that Canadian police force:

(c) the daily quantity of dried marihuana that is specified in the medical document supporting the client’s registration or that is specified in that individual’s registration with the Minister made under Part 2.

Marginal note:Verification

(2) Before providing the requested information, the licensed producer must verify in a reasonable manner that the person requesting the information is a member of a Canadian police force.

Marginal note:Use of information

(3) Information provided under this section must be used only for the purposes of the investigation referred to in subsection (1) and for the proper administration or enforcement of the Act or these Regulations.

(a) a person who is, or was, registered and entitled under the laws of a province to practise medicine in that province; or

(b) a person who is, or was, a nurse practitioner as defined in section 1 of the New Classes of Practitioners Regulations and who is, or was, permitted to prescribe dried marihuana in the province in which they practise or practised.

Marginal note:Information concerning health care practitioners

123(1) A licensed producer must provide in writing, as soon as feasible, any factual information about a health care practitioner that has been obtained under the Act or these Regulations to the licensing authority that is responsible for the registration or authorization of persons to practise the profession

(a) in a province in which the practitioner is, or was, authorized to practise, if the authority submits to the licensed producer a written request that sets out the practitioner’s name and address, a description of the information being sought and a declaration that the information is required for the purpose of assisting an official investigation by the authority; or

(b) in a province in which the practitioner is not authorized to practise, if the authority submits to the licensed producer

(i) a written request that sets out the practitioner’s name and address and a description of the information being sought, and

(A) documentation that shows that the practitioner has applied to that authority to practise in that province, or

(B) documentation that shows that the authority has reasonable grounds to believe that the practitioner is practising in that province without being authorized to do so.

Marginal note:Factual information

(2) The factual information that may be requested includes information — notably patient information — contained in, or in respect of,

(a) any medical document that has been signed by the practitioner and that has formed the basis for registering a client;

(b) any authorization to possess that has formed the basis for registering a client and that was issued under the former Marihuana Medical Access Regulations on the basis of a medical declaration that was made by the practitioner; and

(c) any medical declaration that was made by the practitioner under those former Regulations and that has formed the basis for registering a client.

Marginal note:Exception

(3) The factual information that may be requested does not include information relating to clients who have registered with the licensed producer on the basis of a registration with the Minister made under Part 2.

Marginal note:Secure transmission

(4) A licensed producer must ensure that the information that they provide under this section is securely transmitted.

Marginal note:Quarterly reports to licensing authorities

124(1) A licensing authority that is responsible for the registration or authorization of persons to practise medicine or nursing in a province may submit a written request to a licensed producer to obtain information, on a quarterly basis, in respect of each client who is registered by the producer on the basis of a medical document that was signed by a health care practitioner who was entitled, at the time of the verification performed in accordance with section 132, to practise the relevant profession in the province and was consulted in that province.

Marginal note:Information

(2) A licensed producer who receives a request must, after the end of each quarter and in accordance with subsection (3), provide the licensing authority with the following information in respect of each client referred to in subsection (1) who was validly registered at any time during the relevant quarter, together with details of any changes to the information that have occurred during the quarter:

(b) the postal code for, and the name of the province specified in, the address provided under subparagraph 130(1)(b)(i) or (ii);

(c) the given name, surname and business address of the health care practitioner who signed the medical document and the number assigned by the province to the practitioner’s authorization to practise;

(d) the daily quantity of dried marihuana that is specified in the medical document;

(a) April 30 of a given year for the quarter beginning on January 1 and ending on March 31 of that year;

(b) July 31 of a given year for the quarter beginning on April 1 and ending on June 30 of that year;

(c) October 31 of a given year for the quarter beginning on July 1 and ending on September 30 of that year; and

(d) January 31 of a given year for the quarter beginning on October 1 and ending on December 31 of the previous year.

Marginal note:Initial report

(4) For greater certainty, for the purposes of subsection (2), the first quarter in respect of which information must be provided is the quarter in which the request is received.

Marginal note:No information to provide

(5) If the licensed producer has no information to provide for a quarter, they must send a notice to that effect to the licensing authority by the relevant deadline referred to in subsection (3).

Marginal note:Deadline — ceasing activities

(6) If the licensed producer ceases to conduct activities, any information that they are required to provide to the licensing authority must, despite subsection (3), be provided no later than 30 days after the activities cease.

Marginal note:Revocation notice

(7) The licensing authority may, at any time, send the licensed producer a notice revoking the request referred to in subsection (1), in which case the final quarter in respect of which information must be provided to the authority is the one that precedes the quarter in which the notice is received.

Marginal note:Transmission of information

(8) A licensed producer, or former licensed producer, who provides information to a licensing authority under this section must

(a) ensure that the information is securely transmitted in accordance with the specifications set out in the Directive on the Electronic Transmission of Information Under the Controlled Drugs and Substances Act published by the Department of Health, as amended from time to time; and

(b) provide the information only in an electronic format that is set out in that directive.

Marginal note:Information concerning licensed producers

125 The Minister is authorized to provide any information set out in a notice referred to in section 48, 49 or 50 to a Canadian police force or a member of a Canadian police force who requests the information in the course of an investigation under the Act or these Regulations, subject to that information being used only for the purposes of that investigation and the proper administration or enforcement of the Act or these Regulations.

Marginal note:Information concerning import or export permit

126 The Minister is authorized, for the purpose of verifying whether an importation or exportation of marihuana or a substance referred to in paragraph 22(3)(c) complies with this Part, to provide to a customs officer in Canada any information referred to in sections 94, 95, 98, 102, 103 and 106 and to inform them whether a permit has been suspended or revoked.

Marginal note:Providing information to foreign organizations

127 The Minister is authorized, for the proper administration or enforcement of the Act or these Regulations and for the purpose of enabling Canada to fulfill its international obligations under article 12 of the United Nations Single Convention on Narcotic Drugs, 1961, to provide the following information and documents to the International Narcotics Control Board or a competent authority:

(a) any information or document that a licensed producer is required to provide to the Minister under this Division;

(b) any information pertaining to an activity authorized by a licence or permit issued to a licensed producer under this Part, including the licensed producer’s name, the nature of the authorized activity and any conditions specified in the licence or permit;

(c) in respect of cannabis that a licensed producer receives from another licensed producer or a licensed dealer, the following information:

(i) in the case of fresh or dried marihuana or cannabis oil, its quantity and the date on which it was received, or

(ii) in the case of cannabis other than substances referred to in subparagraph (i), the name of the substance in question, its quantity and the date on which it was received;

(d) in respect of an order that a licensed producer fills under section 143, the quantity of fresh or dried marihuana, cannabis oil or marihuana plants or seeds and the date on which it was shipped;

(e) in respect of an order that a licensed producer fills under subsection 149(1) or (2), the following information:

(i) in the case of dried marihuana, its quantity and the date on which it was shipped, or

(ii) in the case of cannabis other than dried marihuana, the name of the substance in question, its quantity and the date on which it was shipped;

(f) any record that a licensed producer is required to keep under subsection 161(2) or section 163, 164 or 166; and

128 The Minister is authorized to communicate to a law enforcement agency information concerning an application for a security clearance for the purpose of conducting the checks referred to in section 111, subject to that information being used by that agency only for that purpose.

DIVISION 2Client Registration and Ordering

Registration

Marginal note:Eligibility

129 An individual is eligible to be a client of a licensed producer only if they ordinarily reside in Canada.

Marginal note:Registration application

130(1) Before registering an individual as a client, a licensed producer must obtain from the individual or an individual who is responsible for the individual an application that contains the following information, as well as the original of the applicant’s medical document or a copy of their registration certificate issued by the Minister under Part 2:

(i) the address of the place in Canada where the applicant ordinarily resides, as well as, if applicable, the applicant’s telephone number, facsimile number and email address, or

(ii) if the applicant ordinarily resides in Canada but has no dwelling place, the address, as well as, if applicable, the telephone number, facsimile number and email address of a shelter, hostel or similar institution, located in Canada, that provides food, lodging or other social services to the applicant;

(c) the mailing address of the place referred to in paragraph (b), if different from the address provided under that paragraph;

(d) if applicable, the given name, surname, date of birth and gender of one or more individuals who are responsible for the applicant;

(e) if the place referred to in subparagraph (b)(i) is an establishment that is not a private residence, the type and name of the establishment;

(f) an indication as to which of the following is to be their shipping address for fresh or dried marihuana or cannabis oil:

(ii) the mailing address of the place referred to in subparagraph (b)(i), or

(iii) the address of the health care practitioner who provided the medical document, if the practitioner has given their consent under section 131 to receive the shipment on behalf of the applicant; and

(g) in the case of a registration application that is made on the basis of a registration with the Minister made under Part 2,

(i) an indication as to whether the application is being made for the purpose of obtaining

(3) An application that is supported by a copy of a registration certificate issued by the Minister under Part 2 must be signed and dated by the applicant or an individual who is responsible for the applicant and include a statement that

(b) the information in the application and the registration certificate is correct and complete; and

(c) if the application is being made for the purpose of obtaining fresh or dried marihuana or cannabis oil,

(i) the registration certificate is not being used to seek or obtain those substances from another source, and

(ii) the applicant will use those substances only for their own medical purposes.

Marginal note:Statement by responsible individual

(4) If the application is signed and dated by an individual who is responsible for the applicant, it must include a statement by that individual that they are responsible for the applicant.

Marginal note:Homeless applicant

(5) If an application includes the information referred to in subparagraph (1)(b)(ii), the applicant must include with the application an attestation of residence signed and dated by a manager of the specified shelter, hostel or similar institution confirming that the institution provides food, lodging or other social services to the applicant.

Marginal note:Health care practitioner’s consent to receive substance

131(1) If the shipping address specified in a registration application is the one referred to in subparagraph 130(1)(f)(iii), the applicant must include with the application a statement signed and dated by the health care practitioner who provided the medical document to the applicant indicating that the practitioner consents to receive fresh or dried marihuana or cannabis oil on behalf of the applicant.

Marginal note:Withdrawal of consent

(2) If the applicant becomes a client of a licensed producer in accordance with section 133 and the health care practitioner ceases to consent to receive that substance on behalf of the client, the practitioner must send a written notice to that effect to the client and the licensed producer.

Marginal note:No further shipments

(3) A licensed producer who receives such a notice must not send any further shipments of that substance to that health care practitioner for that client.

Marginal note:Amendment to registration

(4) A client who receives such a notice and wishes to specify a new shipping address must submit to the licensed producer a registration amendment application in accordance with section 137.

Marginal note:Verification of medical document

132(1) A licensed producer who receives an application under section 130 that is supported by a medical document and who intends to register the applicant must ensure that

(a) the medical document that supports the application meets all of the requirements of section 8;

(c) the applicant has consulted with the person referred to in paragraph (b) and the information set out in the medical document is correct and complete, as confirmed by the office of that person.

Marginal note:Exception

(2) The licensed producer is not required to do the verifications referred to in paragraph (1)(c) if the signature of the health care practitioner who provided the medical document is known to the producer.

Marginal note:Registration of client

133(1) Subject to section 135, a licensed producer may register an applicant as a client.

Marginal note:Registration document and unique identifier

(2) If the licensed producer registers the applicant as a client, the producer must

(a) send the client a registration document that contains the following information:

(d) the medical document that is submitted with the application is no longer valid;

(e) the registration with the Minister made under Part 2 that supports the application has expired or been cancelled;

(f) the given name, surname or date of birth of the applicant is different from the given name, surname or date of birth that appears on the medical document or the registration certificate issued by the Minister under Part 2;

(g) the health care practitioner who provided the medical document to the applicant notifies the licensed producer in writing that the use of dried marihuana by the applicant is no longer supported for clinical reasons;

(h) in the case of an application that is being made for the purpose of obtaining fresh or dried marihuana or cannabis oil and that is supported by a registration with the Minister made under Part 2, the registration certificate has been used to seek or obtain those substances from another source; or

(i) the address specified in the application under subparagraph 130(1)(b)(i) or (ii) is not in Canada.

Marginal note:Verification

(2) If a licensed producer has reasonable grounds to believe that a medical document submitted with an application is false or falsified, they must, before refusing to register the applicant, verify the validity of the document by contacting the office of the health care practitioner who purportedly signed the document.

Marginal note:Notice to Minister

(3) If a licensed producer refuses to register an applicant whose application is supported by a registration with the Minister made under Part 2, they must notify the Minister of the refusal and provide the Minister with the following information:

(a) the given name and surname of the person named in the Part 2 registration;

136(1) A licensed producer who proposes to refuse to register an applicant for a ground set out in subsection 135(1) or for a business reason must without delay send the applicant a notice that indicates the reason for the proposed refusal.

Marginal note:Opportunity to be heard

(2) The applicant may, within 10 days after receipt of the notice, provide the licensed producer with reasons why the refusal is unfounded.

Marginal note:Return of medical document

(3) A licensed producer who refuses to register an applicant must return to the applicant without delay any medical document that was submitted with the application.

Marginal note:Application to amend registration

137(1) An application to amend a registration must be made to the licensed producer by the client or an individual who is responsible for the client when a change occurs in respect of any of the information provided under subsection 130(1).

(4) If the application is signed and dated by an individual who is responsible for the client, it must include a statement by that individual that they are responsible for the client.

Marginal note:Amendment

138(1) A licensed producer must amend a client’s registration if the client’s amendment application meets the requirements of subsections 137(2) and (3).

Marginal note:Amended registration document

(2) If the licensed producer amends the client’s registration, the producer must send the client an amended registration document that contains the information referred to in subparagraphs 133(2)(a)(i) and (ii).

Marginal note:Cancellation of registration

139(1) A licensed producer must cancel the registration of a client if

(a) the client or an individual who is responsible for the client requests the licensed producer to cancel the registration;

(b) the client dies, ceases to ordinarily reside in Canada or ceases to have a shipping address in Canada;

(i) the registration was made on the basis of false or misleading information submitted in, or false or falsified documents submitted with, the registration application, or

(ii) false or misleading information was submitted in, or false or falsified documents were submitted with, the application to amend the registration;

(d) the health care practitioner who provided the medical document to the client notifies the licensed producer in writing that the use of dried marihuana by the client is no longer supported for clinical reasons;

(e) the health care practitioner who provided the medical document to the client is named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations; or

(f) the licensed producer is notified that the registration with the Minister made under Part 2 that supports the registration with the producer has been cancelled.

Marginal note:Time of cancellation

(2) The licensed producer must cancel the registration of the client without delay if the producer

(a) receives a request referred to in paragraph (1)(a) or a written notice under paragraph (1)(d);

(b) becomes aware of a ground referred to in paragraph (1)(b), (e) or (f) and has verified in a reasonable manner the existence of the ground; or

(c) has reasonable grounds to believe that a ground referred to in subparagraph (1)(c)(i) or (ii) exists.

Marginal note:Cancellation by producer for business reason

(3) A licensed producer may also cancel the registration of a client for a business reason.

Marginal note:Notice

(4) Except in the case of the death of a client, a licensed producer who proposes to cancel a client’s registration under subsection (1) or (3) must without delay send a notice that indicates the reason for the cancellation to the client.

Marginal note:Opportunity to be heard

(5) The client or an individual who is responsible for the client may, within 10 days after receipt of the notice referred to in subsection (4), provide the licensed producer with reasons why the cancellation is unfounded.

(b) send a notice to each client that indicates the reason for the cancellation.

Marginal note:Medical document

(7) A licensed producer who cancels a client’s registration must not return the medical document.

Marginal note:Notice to Minister

(8) If a licensed producer cancels a registration that is supported by a registration with the Minister made under Part 2, they must notify the Minister of the cancellation and provide the Minister with the following information:

(a) the given name and surname of the person named in the Part 2 registration;

(a) a medical document on the basis of which a client has been registered; or

(b) a copy of a registration certificate issued by the Minister under Part 2 on the basis of which a client has been registered.

New Medical Document or Registration Certificate

Marginal note:New application – new medical document

141(1) A licensed producer must not sell or provide fresh or dried marihuana or cannabis oil to a client or an individual who is responsible for the client on the basis of a new medical document unless the client or the individual submits to the producer a new registration application that meets the requirements of section 130.

Marginal note:New application – new registration certificate

(2) A licensed producer must not sell or provide fresh or dried marihuana, cannabis oil or marihuana plants or seeds to a client or an individual who is responsible for the client on the basis of a new registration certificate issued by the Minister under Part 2 unless the client or the individual submits to the producer a new registration application that meets the requirements of section 130.

Processing an Order

Marginal note:Order required

143(1) A licensed producer must not sell or provide fresh or dried marihuana, cannabis oil or marihuana plants or seeds to a client or an individual who is responsible for the client unless the producer has first received, from the client or the individual, a written order in accordance with subsection (2) or a verbal order recorded in accordance with subsection (3).

(c) specify the name of the substance being ordered and its quantity and brand name.

Marginal note:Verbal orders

(3) A licensed producer who receives a verbal order must, before filling the order, make a record of the information referred to in section 155.

Marginal note:Shipping

144 In filling an order referred to in section 143, a licensed producer must not transfer physical possession of the fresh or dried marihuana, cannabis oil or marihuana plants or seeds to the client or to an individual who is responsible for that client other than by shipping it to that person.

Marginal note:Refusal

145(1) A licensed producer must refuse to fill an order referred to in section 143 if

(b) any of the information that is referred to in subparagraph 143(2)(b)(i) or (iii) does not correspond to the information set out in the client’s registration document in accordance with clause 133(2)(a)(ii)(A) or (C);

(c) the client’s unique identifier referred to in subparagraph 143(2)(b)(iv) is not correct;

(e) the order specifies a quantity of fresh or dried marihuana or cannabis oil that exceeds the equivalent of 150 g of dried marihuana;

(f) the order specifies a total quantity of marihuana plants and seeds that, taking into account the equivalency factor specified in subsection (2), exceeds the equivalent of the maximum number of plants, determined in accordance with section 190, that are authorized to be under production under the client’s registration with the Minister made under Part 2;

(h) more than 30 days have elapsed since the date referred to in paragraph 143(2)(a) or 155(a).

Marginal note:Equivalency factor

(2) For the purposes of paragraph (1)(f), three marihuana seeds are equivalent to one marihuana plant.

Marginal note:Notice of refusal

(3) The licensed producer must send the client a written notice of the reason for the refusal.

Marginal note:Thirty-day limit

146(1) A licensed producer must not sell or provide to a client or an individual who is responsible for the client in a 30-day period a total quantity of fresh marihuana, dried marihuana and cannabis oil that exceeds the equivalent of 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d).

Marginal note:Date of sale

(2) The quantity is considered to have been sold or provided, for the purposes of subsection (1), on the day on which the licensed producer reasonably anticipates that it will be received by the client.

(a) the 30-day period beginning on the day on which the licensed producer is considered, under subsection (2), to first sell or provide a substance to the client or the individual who is responsible for the client under the client’s current registration with the producer; and

(b) every 30-day period after the period referred to in paragraph (a).

Marginal note:First 30-day period

(4) For the purpose of applying subsection (3), the first 30-day period begins on the day on which the licensed producer is considered, under subsection (2), to first sell or provide a substance to the client or the individual who is responsible for the client after the day on which that subsection comes into force, even if the producer previously sold or provided a substance to them under the client’s current registration with the producer.

Marginal note:Return

(5) If the client or an individual who is responsible for the client returns to the licensed producer a substance that the producer sold or provided to them, the producer may replace the returned substance with an equal quantity, to a maximum of a quantity that does not exceed the equivalent of 150 g of dried marihuana.

Marginal note:Exclusion

(6) The quantity of the substance that the licensed producer provides to the client or an individual who is responsible for the client to replace the returned substance is to be excluded for the purpose of calculating the total quantity referred to in subsection (1).

Marginal note:Return of marihuana plants or seeds

147 If a client or their designated person returns to a licensed producer marihuana plants or seeds that the producer sold or provided to them, the producer may replace the returned plants or seeds with an equal quantity that, taking into account the equivalency factor specified in subsection 145(2), does not exceed the equivalent of the maximum number of plants, determined in accordance with section 190, that are authorized to be under production under the client’s registration with the Minister made under Part 2.

DIVISION 3Clients and Other Authorized Users

Marginal note:Return

148(1) An individual who, in accordance with this Part or subsection 65(2.1) of the Narcotic Control Regulations, obtains fresh or dried marihuana or cannabis oil for their own medical purposes or for those of another individual for whom they are responsible may return the substance to the person who sold or provided it to them if that person accepts the return of the substance.

Marginal note:Marihuana plants or seeds

(2) A client registered on the basis of a registration with the Minister made under Part 2 who obtains marihuana plants or seeds for their own medical purposes, or the designated person of the client who obtains those plants or seeds for the medical purposes of the client, may return them to the licensed producer who sold or provided them to them if the producer accepts the return of the plants or seeds.

Marginal note:Return by shipping

(3) If the individual returns the substance by means of shipping it to the person who sold or provided it to them, they must

(a) ship it in a package that, having regard to the substance being shipped, meets the requirements of paragraph 93(1)(b) or 93(3)(a); and

(b) use a shipping method that meets the requirements of paragraph 93(1)(c).

Marginal note:Return to licensed producer

(4) If the individual returns the substance to the licensed producer who sold or provided it to them, they must do so by shipping it to the producer’s site in accordance with paragraphs (3)(a) and (b).

DIVISION 4Sale or Provision by a Licensed Producer to a Person Other than a Client

Marginal note:Order required — cannabis

149(1) A licensed producer must not sell or provide cannabis under subsection 22(2) unless the producer has first received a written order in accordance with subsection (3) from

(a) in the case of a licensed dealer or another licensed producer, an individual who is authorized to place an order for cannabis on behalf of that dealer or producer; and

(b) in any other case, the person to whom the cannabis is to be sold or provided in accordance with the Act and this Part.

Marginal note:Fresh or dried marihuana or cannabis oil

(2) A licensed producer must not sell or provide fresh or dried marihuana or cannabis oil under subparagraph 22(4)(a)(ii) or (iii) unless the producer has first received a written order in accordance with subsection (3) from

(a) in the case referred to in subparagraph 22(4)(a)(ii), a pharmacist practising in the hospital or a health care practitioner authorized to place orders for that substance on behalf of the hospital; and

(b) in the case referred to in subparagraph 22(4)(a)(iii), the person to whom that substance is to be sold or provided.

(c) specify the substance being ordered and include the following information:

(i) in the case of fresh or dried marihuana or cannabis oil, its quantity and brand name, or

(ii) in the case of cannabis other than cannabis referred to in subparagraph (i), its quantity, description and, if applicable, brand name.

Marginal note:Signature

(4) A licensed producer must verify in a reasonable manner the identity of the person who placed the order if the signature on the order is not known to the producer.

Marginal note:Definition — pharmacist

(5) In this section, pharmacist means a pharmacist as defined in section 2 of the Narcotic Control Regulations who is not named in a notice issued under section 48 of those Regulations that has not been retracted under section 49 of those Regulations.

Marginal note:Shipping

150 In filling an order referred to in subsection 149(2), a licensed producer must not transfer physical possession of the fresh or dried marihuana or cannabis oil to the person to whom it is sold or provided other than by shipping it to them.

Marginal note:Refusal

151(1) A licensed producer must refuse to fill an order referred to in subsection 149(1) or (2) if

(d) an indication of which substance was received, as well as the following information:

(i) in the case of fresh or dried marihuana or cannabis oil, the quantity and, if applicable, brand name, or

(ii) in the case of cannabis other than cannabis referred to in subparagraph (i), its quantity, description, intended use and, if applicable, brand name.

Marginal note:Imported substances

153 A licensed producer who imports marihuana or a substance referred to in paragraph 22(3)(c) must retain a copy of the declaration required by section 98 and of the export permit issued by a competent authority in the country of export.

Marginal note:Exported substances

154 A licensed producer who exports marihuana or a substance referred to in paragraph 22(3)(c) must retain a copy of the declaration required by section 106 and of the import permit issued by a competent authority in the country of final destination.

Marginal note:Record of verbal order

155 A licensed producer who receives a verbal order referred to in subsection 143(3) must record the following information:

(a) records demonstrating that each lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds that they sold or provided under subsection 22(4) or (5) was produced, packaged and labelled in accordance with Subdivisions D and F of Division 1;

(b) a list of all brand names of fresh or dried marihuana, cannabis oil or marihuana plants or seeds that they produced, packaged or labelled;

(c) a copy of the sanitation program referred to in section 72 in use at their site;

(d) a copy of the standard operating procedures referred to in section 73 in use at their site;

(e) documentation concerning the system of control referred to in section 74 in use at their site;

(f) a description of the qualifications of the quality assurance person in respect of the matters referred to in subparagraph 75(1)(a)(ii); and

(g) records of every complaint referred to in paragraph 75(1)(b) and of any corrective action taken.

Marginal note:Sale or provision

(2) A licensed producer who sells or provides fresh or dried marihuana, cannabis oil or marihuana plants or seeds must keep

(a) records of any testing conducted by or on behalf of the licensed producer in respect of any lot or batch of the substance;

(b) records of information necessary for the system of control referred to in section 74; and

(c) a record of the information that the licensed producer is required by section 77 to provide to the Minister in respect of the recall of the substance.

Marginal note:Dried marihuana equivalency factor

162 A licensed producer must keep a record of the information concerning the method that they have used to determine the dried marihuana equivalency factor under section 79.

Marginal note:Lot or batch — marihuana

163(1) A licensed producer must keep a record of the following information concerning each lot or batch of marihuana that they propagate, sow, harvest, dry, package or destroy:

(a) the date on which marihuana plants are propagated by means other than sowing seeds and the number of new plants propagated in this manner;

(b) the date on which marihuana seeds are sown and their net weight on that date;

(c) the date on which marihuana is harvested and its net weight on that date;

(d) the date on which the drying process for marihuana is completed, if any, and its net weight on that date;

(e) the date on which marihuana is packaged and its net weight on that date; and

(f) the date on which marihuana is destroyed and its net weight on that date, before the destruction.

Marginal note:Lot or batch — cannabis oil

(2) A licensed producer must keep a record of the following information concerning each lot or batch of cannabis oil that they produce, package or destroy:

(a) the date on which the oil is produced and its net weight or volume on that date;

(b) if applicable, the date on which the oil is put into a capsule or other similar dosage form and the number of capsules or units of that dosage form;

(c) in respect of the cannabis that was used to produce the oil, its description, its net weight or volume, its lot or batch number and the date on which it was produced;

(d) the date on which the oil is packaged and its net weight or volume on that date; and

(e) the date on which the oil is destroyed and its net weight or volume on that date, before the destruction.

Marginal note:Research and development

164 Every licensed producer must keep a record of the following information concerning cannabis that they use in a research and development activity:

(a) its description, the quantity used, its lot or batch number and, if applicable, its brand name;

(d) the names of the witnesses to the destruction that are referred to in paragraph 30(1)(b) and the basis on which they are qualified to be witnesses under subsection 30(2); and

(e) if applicable, the name of the person who accompanied the cannabis in accordance with subsection 30(3).

Marginal note:Statement by witnesses

(2) A licensed producer must keep, for each instance in which they destroy cannabis, a statement signed and dated by each of the witnesses referred to in paragraph 30(1)(b) stating that they have witnessed the destruction and that the cannabis was destroyed in accordance with section 30.

Marginal note:Inventory — marihuana

166(1) A licensed producer must keep a record of the net weight of each of the following that are in inventory at their site at the end of each quarter of the calendar year:

(a) marihuana seeds, other than marihuana seeds referred to in paragraph (h);

(b) harvested marihuana, other than marihuana referred to in paragraphs (e) and (f), that is not to be subjected to a drying process;

(c) harvested marihuana, other than marihuana referred to in paragraphs (e) and (g), in respect of which the drying process has not been completed;

(d) harvested marihuana, other than marihuana referred to in paragraphs (e) and (g), in respect of which the drying process has been completed;

General Obligations

Marginal note:Manner of keeping records

169(1) A licensed producer must ensure that the records, documents and information referred to in this Division are kept in a manner that will enable an audit of them to be made in a timely manner and are available at their site.

Marginal note:Retention period

(2) A licensed producer must retain the records, documents and information for the following periods:

(a) in the case of a notice that the producer is required to provide or send under this Part, for a period of two years after the day on which the notice is provided or sent;

(b) in the case of information that the producer is required to record under sections 152 and 155, subsection 156(1), section 157, subsections 158(1) and 159(1) and sections 163, 164 and 166, for a period of two years after the day on which the information is recorded;

(c) in the case of the documents referred to in sections 153 and 154, for a period of two years after the day on which the declaration referred to in section 98 or 106, as applicable, is sent to the Minister;

(d) in the case of the documents referred to in subsection 156(2) and paragraphs 159(2)(a) to (f), for a period of two years after the day on which the producer obtained them or, in the case of documents made by the producer, the day on which they were made;

(e) in the case of the visual recordings or the records referred to in section 160, for a period of two years after the day on which they were made;

(f) in the case of the records referred to in paragraphs 161(1)(a) and (2)(b), for a period of two years after the date of the last sale or provision of any portion of the lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds under subsection 22(4) or (5);

(g) in the case of a document referred to in any of paragraphs 161(1)(b) to (e), for the period during which it is current and for an additional period of two years after the day on which it is replaced by a new version;

(h) in the case of a document referred to in paragraph 161(1)(f), for the period during which the quality assurance person acts in that capacity and for an additional period of two years after the day on which the person ceases to do so;

(i) in the case of the records referred to in paragraph 161(1)(g), for a period of two years after the day on which the complaint was recorded;

(j) in the case of the records referred to in paragraph 161(2)(a), for a period of two years after the date of the last sale or provision of any portion of the lot or batch, other than a sale or provision for destruction;

(k) in the case of the records referred to in paragraph 161(2)(c), for a period of two years after the day on which the substance was recalled;

(l) in the case of the information concerning the method referred to in section 162, for a period of two years after the day on which the information is recorded;

(m) in the case of the records and documents referred to in section 165, for a period of two years after the day on which the cannabis was destroyed;

(n) in the case of a document or record referred to in paragraph 168(b), for a period of two years after the day on which the information was provided to the licensing authority;

(o) in the case of a request or notice referred to in paragraph 168(c), for a period of two years after the day on which it was received;

(p) in the case of a document or record referred to in paragraph 168(d), for a period of two years after the day by which the producer was required to provide the information; and

(q) in the case of a notice referred to in paragraph 168(e), for a period of two years after the end of the quarter to which the notice relates.

Marginal note:Case reports and summary reports

(3) A licensed producer must retain the serious adverse reaction case reports and the summary reports referred to in subsections 78(1) and (2), respectively, for a period of 25 years after the day on which they were made.

Marginal note:Information required by Minister

170 A licensed producer must provide the Minister with any information that the Minister may require in respect of the records, documents and information referred to in this Division, in the form and at the times that the Minister specifies.

Marginal note:Former licensed producers

171 If a producer’s licence expires without being renewed or is revoked, the former licensed producer must comply with the requirements of sections 169 and 170.

PART 2Production for Own Medical Purposes and Production by a Designated Person

Interpretation

Marginal note:Definition

172(1) In this Part, production area means the place where the production of marihuana plants is conducted, that is

(2) For the purposes of paragraphs 177(4)(e) and 193(1)(d), a piece of land is considered to be adjacent to another piece of land if its boundary has at least one point in common with the boundary of the other piece of land.

General Provision

Marginal note:Signature and attestation

173 An application, declaration or notice that is required to be submitted under this Part by an applicant or registered person must be signed and dated by them — or an individual who is responsible for them — and attest that the information contained in it is correct and complete.

DIVISION 1Registration with Minister

Marginal note:Eligibility – registered person

174(1) An individual is eligible to be a registered person only if they ordinarily reside in Canada.

Marginal note:Eligibility – production for own medical purposes

(2) An individual is eligible to produce cannabis for their own medical purposes as a registered person only if they are an adult.

Marginal note:Prior offences

(3) An individual is not eligible to conduct the production referred to in subsection (2) if, within the preceding 10 years, they have been convicted, as an adult, of

(a) a designated cannabis offence — or an offence committed outside Canada that, if committed in Canada, would have constituted such an offence — that was committed while they were authorized to produce cannabis under the Act, other than under the former Marihuana Medical Access Regulations; or

(b) a designated marihuana offence — or an offence committed outside Canada that, if committed in Canada, would have constituted such an offence — that was committed while they were authorized to produce marihuana

(a) an offence, in respect of cannabis, under section 5 of the Act, or under section 6 of the Act except with respect to importation; or

(b) a conspiracy or an attempt to commit, or being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction désignée relativement au chanvre indien)

designated marihuana offence

designated marihuana offence means

(a) an offence, in respect of marihuana, under section 5 of the Act, or under section 6 of the Act except with respect to importation; or

(b) a conspiracy or an attempt to commit, or being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction désignée relativement à la marihuana)

(b) have been convicted, as an adult, of an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in paragraph (a);

(c) have been convicted of an offence referred to in paragraph (a) as a young person in ordinary court, as those terms were defined in subsection 2(1) of the Young Offenders Act, chapter Y-1 of the Revised Statutes of Canada, 1985, immediately before that Act was repealed;

(d) were a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act, in respect of an offence referred to in paragraph (a); or

(e) received a sentence — for an offence they committed outside Canada when they were at least 14 years old but less than 18 years old that, if committed in Canada, would have constituted an offence referred to in paragraph (a) — that was longer than the maximum youth sentence that could have been imposed under the Youth Criminal Justice Act for such an offence.

Marginal note:Registration application

177(1) An individual seeking a registration to produce cannabis for their own medical purposes or to have it produced for them by a designated person must submit to the Minister an application that includes the original of the applicant’s medical document and the information and documents required by this section.

Marginal note:Responsible individual

(2) The application and related documents may also be submitted by an individual who is responsible for the applicant, in which case the application must be signed and dated by that individual and include a statement by them that they are responsible for the applicant.

(i) the applicant will comply with the possession limit referred to in section 6, or

(ii) any individual who is responsible for the applicant will comply with that limit and ensure that the applicant complies with it;

(g) an indication as to whether the registration is sought in respect of cannabis to be produced by the applicant or by a designated person named in the application; and

(h) an indication that the applicant or, if applicable, any individual who is responsible for the applicant will take all necessary measures to ensure the security of the cannabis in their possession.

Marginal note:Production for own medical purposes

(4) If the applicant intends to produce cannabis for their own medical purposes, the application must also include

(a) an indication that, within the 10 years preceding the application, they have not been convicted, as an adult, of an offence referred to in paragraph 174(3)(a) or (b);

(b) an indication that they will comply with the limit on the maximum number of plants under production referred to in paragraph 178(2)(l) and the limit on the maximum quantity of dried marihuana in storage referred to in paragraph 178(2)(n);

(c) the full address of the site where the proposed production of marihuana plants is to be conducted;

(e) if the proposed production area involves outdoor production entirely or partly indoor and partly outdoor production, an indication that the production site is not adjacent to a school, public playground, day-care facility or other public place frequented mainly by persons under 18 years of age;

(f) an indication that the cannabis, other than marihuana plants, will be stored indoors and whether it is proposed to store it at

(i) within the 10 years preceding the application, they have not been convicted of an offence referred to in any of paragraphs 176(2)(a) to (c) or received a sentence referred to in paragraph 176(2)(d) or (e),

(ii) that they will take all necessary measures to ensure the security of the marihuana plants and cannabis, and

(iii) they will comply with the limit on the maximum number of plants under production referred to in paragraph 178(2)(l) and the limit on the maximum quantity of dried marihuana in storage referred to in paragraph 178(2)(n); and

(e) a document issued by a Canadian police force establishing that, within the 10 years preceding the application, the designated person has not been convicted of an offence referred to in paragraph 176(2)(a) or (c) or received a sentence referred to in paragraph 176(2)(d).

Marginal note:Signature and attestation of designated person

(6) The declaration referred to in subsection (5) must be signed and dated by the designated person and attest that the information contained in it is correct and complete.

Marginal note:Consent of owner

(7) If the proposed site for the production of marihuana plants is not the ordinary place of residence of the applicant or of the designated person, if any, and is not owned by the applicant or the designated person, the application must include the given name, surname, address and telephone number of the owner of the site and a declaration signed and dated by them consenting to production at the site.

Marginal note:Registration

178(1) Subject to sections 183 to 185, if the requirements of section 177 are met, the Minister must register the applicant.

(e) the name of the health care practitioner who provided the medical document;

(f) the maximum quantity of dried marihuana, in grams, that the registered person or, if applicable, any individual who is responsible for the registered person may possess under the registration, which is the lesser of

(i) 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d), and

(h) the expiry date of the registration, which must correspond to the end of the period of validity of the medical document supporting the registration, as determined in accordance with subsection 8(3);

(i) the type of production that is authorized, namely production for one’s own medical purposes or production by a designated person;

(j) the full address of the site where the production of marihuana plants is authorized;

(l) the maximum number of marihuana plants, determined in accordance with section 190, that may be under production at the production site and, if the production area is partly indoors and partly outdoors, the maximum number of plants for each production period;

(m) the full address of the site where the cannabis may be stored; and

(n) the maximum quantity of dried marihuana, in grams, determined in accordance with section 191, that may be stored at the site authorized under paragraph (m).

(b) send to the designated person, if any, a document containing information relating to the production by the designated person.

Marginal note:Renewal application

179 To apply to renew a registration, the registered person or an individual who is responsible for them must submit to the Minister an application that includes the registration number and the information and documents required under section 177.

Marginal note:Renewal

180(1) Subject to sections 183 to 185, if an application complies with section 179, the Minister must renew the registration and send the renewed registration certificate to the registered person and send to the designated person, if any, an updated version of the document referred to in paragraph 178(3)(b).

Marginal note:Cancellation of existing registration

(2) Before renewing the registration, the Minister must cancel any existing registration .

Marginal note:Notice to former designated person

(3) If a registration is renewed before the expiry of the previous registration and the renewal results in the replacement of a designated person by another or by the registered person, the Minister must notify the former designated person of the loss of their authorization to produce cannabis under that registration.

Marginal note:Amendment application

181(1) Subject to subsection (3), the registered person or an individual who is responsible for them must submit to the Minister an amendment application in respect of a change to any of the information set out in the registration.

(c) in the case of a change in the given name or surname of the registered person, the designated person or an individual who is responsible for the registered person, proof of the change.

Marginal note:New application concerning new medical document

(3) In the case of a new medical document, a new registration application must be submitted under section 177.

Marginal note:Amendment

182(1) Subject to sections 183 to 185, if an application complies with section 181, the Minister must amend the registration and, if applicable, send an amended registration certificate to the registered person and send to the designated person, if any, an updated version of the document referred to in paragraph 178(3)(b).

Marginal note:Notice to former designated person

(2) If the amendment results in the replacement of a designated person by another or by the registered person, the Minister must notify the former designated person of the loss of their authorization to produce cannabis under that registration.

Marginal note:Change of site

(3) If the Minister amends a registration in respect of a change in the location of the authorized site for the production of marihuana plants or the authorized site for the storage of cannabis, the Minister may specify the period during which the registered person or the designated person, if any, may transport cannabis from the former site to the new site.

Marginal note:Grounds for refusal — registration

183 The Minister must refuse to register an applicant or renew or amend a registration if

(a) the applicant is not eligible under subsection 174(1) or section 175;

(b) the medical document that supports the application does not meet all of the requirements of section 8 or is no longer valid;

(d) the given name, surname or date of birth of the applicant is different from the given name, surname or date of birth that appears on the medical document;

(e) the health care practitioner who provided the medical document to the applicant notifies the Minister in writing that the use of dried marihuana by the applicant is no longer supported for clinical reasons; or

(f) any information, declaration or other item included in the application is false or misleading.

Marginal note:Grounds for refusal — production for own medical purposes

184 In the case of an application for a registration to produce for own’s own medical purposes or an application to renew or amend such a registration, the Minister must refuse to register the applicant or to renew or amend the registration if

(b) the person would become authorized to produce marihuana plants under more than two registrations;

(c) the proposed site for the production of marihuana plants would be a production site under more than four registrations; or

(d) any information, declaration or other item included in the application is false or misleading.

Marginal note:Grounds for refusal — designated person

185 In the case of an application for a registration for production by a designated person or an application to renew or amend such a registration, the Minister must refuse to register the applicant or to renew or amend the registration

DIVISION 2Production

Authorized Activities

187 A registered person whose registration authorizes them to produce cannabis for their own medical purposes may, in accordance with their registration and the provisions of this Part,

(a) produce for their own medical purposes marihuana plants or cannabis other than marihuana plants;

(b) store, for their own medical purposes, a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that may be stored under the registration;

(c) transport directly, from the site for the storage of cannabis to the site for the production of marihuana plants, a total quantity of marihuana plants and seeds that, taking into account the equivalency factor specified in subsection 145(2), does not exceed the equivalent of the maximum number of plants, determined in accordance with section 190, that are authorized to be under production under the registration;

(d) if the site for the production of marihuana plants is different from the place where the registered person ordinarily resides, transport directly from that site to that place a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that may be stored under the registration; and

(e) if there is a change in the location of the site for the production of marihuana plants or the site for the storage of cannabis, transport cannabis directly from the former site to the new site.

Marginal note:Registered person who has a designated person

188 A registered person whose registration specifies a designated person may, if they are an adult, participate in the activities that the designated person is authorized to conduct under the registration.

Marginal note:Designated person

189(1) A designated person may, in accordance with the registration and the provisions of this Part,

(a) produce, for the medical purposes of the registered person, marihuana plants or cannabis other than marihuana plants;

(b) store, for the purpose mentioned in paragraph (a), a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that may be stored under the registration;

(c) transport directly, from the site for the storage of cannabis to the site for the production of marihuana plants, a total quantity of marihuana plants and seeds that, taking into account the equivalency factor specified in subsection 145(2), does not exceed the equivalent of the maximum number of plants, determined in accordance with section 190, that are authorized to be under production under the registration;

(d) if the site for the production of marihuana plants is different from the site for the storage of cannabis, transport directly from the first to the second site a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that may be stored under the registration;

(e) subject to subsection (2), if the site for the storage of cannabis is different from the place where the registered person ordinarily resides, transport directly or ship from that site to that place a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that the registered person may possess under paragraph 178(2)(f);

(f) if there is a change in the location of the site for the production of marihuana plants or the site for the storage of cannabis, transport cannabis directly from the former site to the new site; and

(g) provide or deliver for the registered person a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that the registered person may possess under paragraph 178(2)(f).

Marginal note:Security when shipping

(2) A designated person shipping cannabis in the circumstances referred to in paragraph (1)(e) must take the measures specified in paragraphs 93(1)(b) and (c).

(a) if the production area is entirely indoors or outdoors, the maximum number of marihuana plants that the registered person or designated person is authorized to produce, calculated under paragraph 190(2)(a) or (b), whichever applies, or

(b) if the production area is partly indoors and partly outdoors, the maximum number of marihuana plants that the registered person or designated person is authorized to produce, calculated under subparagraph 190(2)(c)(ii); and

F

is the maximum quantity of dried marihuana, in grams, that may be stored under the registration.

Marginal note:Calculation

(2) The maximum quantity of dried marihuana that may be stored under the registration is determined according to whichever of the following formulas applies:

192 A person who is authorized by a registration to produce cannabis must not store a total quantity of fresh marihuana, dried marihuana and any products referred to in paragraphs 4(1)(b) and (c) that exceeds the equivalent of the maximum quantity of dried marihuana that may be stored under the registration, as calculated under section 191.

Marginal note:Location and type of production

193(1) A person who is authorized by a registration to produce cannabis

(a) may only produce marihuana plants at the authorized site for the production of marihuana plants;

(b) may only produce cannabis, other than marihuana plants, at the site for the production of marihuana plants or at the site for the storage of cannabis;

(c) must not cultivate, harvest or propagate marihuana partly indoors and partly outdoors simultaneously; and

(d) must not cultivate, harvest or propagate marihuana outdoors if the production site is adjacent to a school, public playground, day-care facility or other public place frequented mainly by persons under 18 years of age.

Marginal note:Exception

(2) A registered person or an individual responsible for them may produce a quantity of cannabis, other than marihuana plants, at a location other than one specified in paragraph (1)(b) if the quantity produced does not exceed the equivalent of the maximum quantity of dried marihuana that they may possess under paragraph 178(2)(f).

Marginal note:Transport of plants

(3) If marihuana plants are shipped by a licensed producer to the site for the storage of cannabis, the person who is authorized by the registration to produce cannabis must transport the plants directly from that site to the site for the production of marihuana plants within seven days after the day on which the plants are received.

Marginal note:Storage at specified site

194 A person who is authorized by a registration to produce cannabis may store cannabis, other than marihuana plants, only indoors at the site authorized in the registration for that purpose.

Marginal note:Inspection

195(1) To verify that the production of cannabis is in accordance with these Regulations and a registration, an inspector may, at any reasonable time, enter any place where the inspector believes on reasonable grounds that cannabis is being produced or stored by a registered person or a designated person, and may, for that purpose,

(a) open and examine any receptacle or package found there that could contain cannabis;

(b) examine anything found there that is used or may be capable of being used to produce or store cannabis;

(c) examine any substance found there and, for the purpose of analysis, take samples; and

(d) seize and detain, in accordance with Part IV of the Act, any substance found there, if the inspector believes, on reasonable grounds, that it is necessary.

Marginal note:Consent

(2) An inspector may not enter a dwelling place without the consent of an occupant of the dwelling place.

Marginal note:Provisions of the Act

(3) Subsections 31(6) to (9) of the Act apply, with the necessary modifications, to an inspection under this section.

DIVISION 3General Obligations

Marginal note:Security

196(1) A registered person or, if applicable, an individual who is responsible for them must maintain measures necessary to ensure the security of the cannabis in their possession and the registration certificate.

Marginal note:Reporting loss or theft

(2) In the case of the loss or theft of cannabis or the registration certificate, the registered person or the individual who is responsible for them must

(a) within the 24 hours after becoming aware of the occurrence, notify a police force; and

(b) within the next 72 hours after becoming aware of the occurrence, notify the Minister, in writing, and include confirmation that the notice required under paragraph (a) has been given.

Marginal note:Designated person

(3) The requirements specified in subsections (1) and (2) also apply to a designated person in regard to cannabis in their possession and the document referred to in paragraph 178(3)(b).

Marginal note:Cancellation of registration

197(1) Subject to section 198, the Minister must cancel a registration if

(d) the registration was issued on the basis of false or misleading information;

(e) the health care practitioner who provided the medical document to the registered person notifies the Minister in writing that the use of dried marihuana by the person is no longer supported for clinical reasons;

(f) the health care practitioner who provided the medical document to the registered person is named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations;

(g) the registered person or an individual who is responsible for them requests the Minister to cancel the registration; or

(h) the registered person dies or ceases to ordinarily reside in Canada.

Marginal note:Cancelling excess registrations

(2) Subject to section 198, if a site for the production of marihuana plants is authorized under more than four registrations, the Minister must cancel the excess registrations.

Marginal note:Communication to licensed producer

(3) If a registration is cancelled and the Minister is aware that the registration has formed the basis for registering with a licensed producer under Part 1, the Minister must notify the producer of the cancellation and provide them with the following information:

(a) the given name and surname of the person named in the cancelled registration;

(a) the Minister has sent the registered person a notice of the reasons for the proposed cancellation and has given them an opportunity to be heard;

(b) the Minister has sent the designated person, if any, a notice of the proposed cancellation; and

(c) the failure that gave rise to the proposed cancellation is not rectified.

Marginal note:Destruction of cannabis — registered person

199(1) A registered person who ceases to be authorized to produce marihuana plants under their registration must discontinue production of those plants and, subject to subsection (2), destroy all cannabis in their possession.

Marginal note:Exception

(2) The registered person is not required to destroy cannabis that is not in excess of the equivalent of the maximum quantity of dried marihuana that they may possess under paragraph 178(2)(f).

Marginal note:Destruction of cannabis — designated person

200(1) A designated person who ceases to be authorized to produce cannabis under a registration must discontinue production of cannabis and, subject to subsection (2), destroy all cannabis in their possession.

Marginal note:Exception

(2) The person may, before destroying cannabis, transport, transfer, give or deliver, without delay, directly to the registered person, or an individual who is responsible for them, a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that the registered person may possess under paragraph 178(2)(f).

Marginal note:Destruction of cannabis — change in production area

201 If a registration is amended under section 182 or at the time of the renewal to reflect a change in the production area, the person authorized to produce cannabis must destroy

(a) any marihuana plants under production that are in excess of the maximum number of plants that may be produced under the registration, as amended; and

(b) any cannabis that they are storing that is in excess of the equivalent of the maximum quantity of dried marihuana that may be stored under the registration, as amended.

Marginal note:Communication of information – police

202 The Minister is authorized to provide any of the following information to a Canadian police force or a member of a Canadian police force who requests the information in the course of an investigation under the Act or these Regulations, subject to that information being used only for the purposes of that investigation and the proper administration or enforcement of the Act or these Regulations:

(a) in respect of a named individual, whether the individual is a registered person, a designated person or an individual who is responsible for the registered person;

(i) the place where a registered person or a designated person ordinarily resides and, if so, the name of that person and the registration number,

(ii) the site where the production of marihuana plants is authorized under a registration and, if so, the registration number, the name of the person who is authorized to produce and, if that person is a designated person, the name of the registered person who may participate in the production, or

(iii) the site where cannabis may be stored under a registration and, if so, the information referred to in subparagraph (ii); and

(xi) the maximum quantity of dried marihuana that may be stored at the site referred to in subparagraph (x).

Marginal note:Communication of information — licensing authorities

203(1) The Minister is authorized to provide, in respect of a health care practitioner who provided a medical document that formed the basis for a registration with the Minister, the following information to the provincial professional licensing authority that is responsible for the registration or authorization of persons to practise their profession in the province identified in the document as the province in which the practitioner is authorized to practise:

(a) the given name, surname and date of birth of the person who registered with the Minister;

(b) the postal code for, and the name of the province specified in, the address of the place where the registered person ordinarily resides;

(c) the given name, surname and business address of the health care practitioner who signed the medical document and the number assigned by the province to the practitioner’s authorization to practise;

(d) the daily quantity of dried marihuana that is specified in the medical document;

(f) the date on which the medical document was signed by the health care practitioner.

Definition of health care practitioner

(2) In this section, health care practitioner has the same meaning as in section 122.

[204 to 253 reserved]

PART 3Transitional Provisions

Definition of Licensed Producers Exemption

254 In this Part, Licensed Producers Exemption means the Section 56 Class Exemption for Licensed Producers Under the Marihuana for Medical Purposes Regulations to Conduct Activities with Cannabis issued by the Minister on July 8, 2015.

(2) A supplemental licence issued in relation to the Licensed Producers Exemption is deemed to be continued under these Regulations as a producer’s licence and remains valid until it expires or is revoked.

257 A licensed producer who sells or provides dried marihuana under subsection 22(4) may, during the 180-day period after the day on which these Regulations come into force, comply with the packaging and labelling provisions of the former Marihuana for Medical Purposes Regulations instead of those of these Regulations.

258 A licensed producer who sells or provides fresh marihuana or cannabis oil under subsection 22(4) may, during the 180-day period after the day on which these Regulations come into force, comply with the packaging and labelling provisions of the Licensed Producers Exemption instead of those of these Regulations.

Marginal note:Sale or provision of marihuana plants or seeds

259 If a producer’s licence that authorizes the sale or provision of dried marihuana was issued under the former Marihuana for Medical Purposes Regulations and is continued under these Regulations, the licensed producer may, pursuant to that licence and in accordance with these Regulations, sell or provide marihuana plants or seeds under section 22(5) of these Regulations until the earlier of

(a) the 180th day after the day on which these Regulations come into force, and

260(1) If any of the following applications has been submitted under the former Marihuana for Medical Purposes Regulations but the Minister has not made a decision to approve or refuse the application before the day on which these Regulations come into force, it must be processed as an application under these Regulations:

(a) an application for a producer’s licence or an application to renew or amend a producer’s licence;

(2) If an application for a supplemental licence or an application to renew or amend a supplemental licence in relation to the Licensed Producers Exemption has been submitted but the Minister has not made a decision to approve or refuse the application before the day on which these Regulations come into force, it must be processed as an application under these Regulations to amend the producer’s licence to which it relates.

Marginal note:Applications for security clearances

(3) If an application for a security clearance has been submitted under the former Marihuana for Medical Purposes Regulations but the Minister has not made a decision to approve or refuse the application before the day on which these Regulations come into force, it must be processed as an application under these Regulations.

PART 4Consequential Amendments, Repeal, Application and Coming into Force